Formulations for weight loss and methods of use

ABSTRACT

A weight loss composition including banaba leaf extract, apple fruit extract,  Rhodiola  root extract, zinc chelate, and magnesium chelate are described. The weight loss composition may further include  gardenia  fruit extract, chromium chelate,  Salacia  extract, berberine, inositol, or mixtures thereof. Embodiments are also directed to a bulk food product and a weight management plan, which may be used in conjunction with the weight loss composition. Embodiments are also directed to kits and methods of use for treating or preventing obesity, promoting weight loss, and improving insulin resistance.

PRIORITY PARAGRAPH

This application claims priority to the U.S. Provisional Application No.62/443,117, filed on Feb. 2, 2017, titled, “Formulations For Weight Lossand Methods of Use”, which is incorporated herein by reference.

SUMMARY

Embodiments herein are directed to a weight loss composition includingbanaba leaf extract, rhodiola root extract, apple fruit extract, zinc,and magnesium. In some embodiments, the zinc and/or magnesium are inchelated form. In some embodiments, the weight loss compositioncomprises banaba leaf extract in an amount of about 10 mg to about 100mg, apple fruit extract in an amount greater than about 30 mg, Rhodiolaroot extract in an amount of about 140 mg to about 500 mg, magnesium inan amount of about 10 mg to about 75 mg, and zinc in an amount greaterthan about 15 mg. In some embodiments, the zinc and/or magnesium are inchelated form. In some embodiments, the weight loss composition mayfurther comprise at least one of the following: chromium chelate,gardenia fruit extract, salacia extract, inositol, and berberinehydrochloride.

Some embodiments are directed to a method for promoting weight loss in asubject comprising administering to the subject a weight losscomposition including banaba leaf extract, rhodiola root extract, applefruit extract, zinc, and magnesium. In some embodiments, the zinc and/ormagnesium are in chelated form. Some embodiments are directed to amethod of treating or preventing obesity in a subject comprisingadministering to the subject a weight loss composition including banabaleaf extract, rhodiola root extract, apple fruit extract, zinc, andmagnesium. In some embodiments, the zinc and/or magnesium are inchelated form. Some embodiments are directed to a method of improvinginsulin resistance in a subject comprising administering to the subjecta weight loss composition including banaba leaf extract, rhodiola rootextract, apple fruit extract, zinc, and magnesium. In some embodiments,the zinc and/or magnesium are in chelated form.

Some embodiments are directed to a method for promoting weight loss in asubject comprising administering to the subject a weight losscomposition including banaba leaf extract, rhodiola root extract, applefruit extract, zinc, and magnesium. In some embodiments, the zinc and/ormagnesium are in chelated form. Some embodiments are directed to amethod for promoting weight loss in a subject in need thereof comprisingadministering to the subject a weight loss composition including banabaleaf extract, rhodiola root extract, apple fruit extract, zinc, andmagnesium, wherein the subject is following a weight management plandesigned to stabilize and optimize insulin levels. In some embodiments,the zinc and/or magnesium are in chelated form. Some embodiments aredirected to a method for promoting weight loss in a subject in needthereof comprising administering to the subject a weight losscomposition including banaba leaf extract, rhodiola root extract, applefruit extract, zinc, and magnesium; and a bulk food product ofembodiments herein, wherein the subject is following a weight managementplan of embodiments herein designed to stabilize and optimize insulinlevels. In some embodiments, the zinc and/or magnesium are in chelatedform.

Some embodiments are directed to a method of treating or preventingobesity in a subject comprising administering to the subject a weightloss composition including banaba leaf extract, rhodiola root extract,apple fruit extract, zinc and magnesium; and a bulk food product ofembodiments herein. Some embodiments are directed to a method oftreating or preventing obesity in a subject in need thereof comprisingadministering to the subject a weight loss composition including banabaleaf extract, rhodiola root extract, apple fruit extract, zinc andmagnesium, wherein the subject is following a weight management plandesigned to stabilize and optimize insulin levels. Some embodiments aredirected to a method of treating or preventing obesity in a subject inneed thereof comprising administering to the subject a weight losscomposition including banaba leaf extract, rhodiola root extract, applefruit extract, zinc and magnesium; and a bulk food product ofembodiments herein, wherein the subject is following a weight managementplan of embodiments herein designed to stabilize and optimize insulinlevels.

Some embodiments are directed to a method of improving insulinresistance in a subject comprising administering to the subject a weightloss composition including banaba leaf extract, rhodiola root extract,apple fruit extract, zinc and magnesium; and a bulk food product ofembodiments herein. Some embodiments are directed to a method ofimproving insulin resistance in a subject in need thereof comprisingadministering to the subject a weight loss composition including banabaleaf extract, rhodiola root extract, apple fruit extract, zinc andmagnesium, wherein the subject is following a weight management plandesigned to stabilize and optimize insulin levels. Some embodiments aredirected to a method of improving insulin resistance in a subject inneed thereof comprising administering to the subject a weight losscomposition including banaba leaf extract, rhodiola root extract, applefruit extract, zinc and magnesium; and a bulk food product ofembodiments herein, wherein the subject is following a weight managementplan of embodiments herein designed to stabilize and optimize insulinlevels.

Some embodiments are directed to a kit comprising a weight losscomposition comprising banaba leaf extract, rhodiola root extract, applefruit extract, zinc and magnesium, and instructions for a weightmanagement plan designed to stabilize and optimize insulin levels.

Some embodiments are directed to a kit comprising a weight losscomposition comprising banaba leaf extract, rhodiola root extract, applefruit extract, zinc and magnesium, and a bulk food product comprisingprotein, fat, carbohydrates, fiber and a phyto blend of at least two ofthe following: mushroom powder, moringa leaf extract, ginger, turmeric,saffron, a natural supplement blend, digestive enzymes, probiotics (e.g.Bacillus subtilis, such as that sold under the tradename DE111™, or B.coagulans, such as that sold under the tradename LactoSpore™), fruits,vegetables, and herbs. In some embodiments, the ginger may be gingerrhizome. In some embodiments, the turmeric may be turmeric rhizome.

Some embodiments are directed to a kit comprising a weight losscomposition comprising banaba leaf extract, rhodiola root extract, applefruit extract, zinc and magnesium, a weight management plan designed tostabilize and optimize insulin levels, and a bulk food product.

DESCRIPTION OF THE FIGURES

FIG. 1 illustrates change in average body weight (lb) and waistcircumference after 7 days, 30 days and 90 days.

FIG. 2 illustrates change in average body weight (lb) and body massindex (BMI) after 26 weeks

FIG. 3 illustrates change in average body weight and BMI after 26 weeksas a percentage of baseline values.

FIG. 4 illustrates change in average fasting blood glucose (FBG) andhemoglobin Ale from baseline to 26 weeks (n=35).

FIG. 5 illustrates change in average blood pressure from baseline to 26weeks (n=35).

FIG. 6 illustrates change in average visceral fat (%) over 26 weeks(p=0.005) and over 39-55 weeks (p<0.00001) (n=35)).

DETAILED DESCRIPTION

This invention is not limited to the particular processes, compositions,or methodologies described, as these may vary. The terminology used inthe description is for the purpose of describing the particular versionsor embodiments only, and is not intended to limit the scope of thepresent invention. Unless defined otherwise, all technical andscientific terms used herein have the same meanings as commonlyunderstood by one of ordinary skill in the art. All publicationsmentioned herein are incorporated by reference in their entirety.Nothing herein is to be construed as an admission that the invention isnot entitled to antedate such disclosure by virtue of prior invention.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural reference unless the context clearly dictatesotherwise. Thus, for example, reference to an “antioxidant” is areference to one or more antioxidants and equivalents thereof known tothose skilled in the art, and so forth.

As used herein, the term “about” means plus or minus 10% of thenumerical value of the number with which it is being used. Therefore,about 50% means in the range of 45%-55%.

As used herein, the term “weight management” refers to weight loss,weight gain or weight maintenance, according to the desired effect.

As used herein, the term “weight loss” refers to weight loss as well asweight maintenance.

“Administering” when used in conjunction with a therapeutic means toadminister a therapeutic to a patient whereby the therapeutic positivelyimpacts the tissue to which it is targeted. Thus, as used herein, theterm “administering”, when used in conjunction with a weight losscomposition, can include, but is not limited to, oral or parenteraladministration. Suitable forms for the weight loss composition for oralor parenteral administration may include tablets, softgels, capsules,lozenges, syrups, granules, solutions and suspensions which contain unitdoses of the supplement for administration once or several times a day.The weight loss composition of the invention may typically beadministered orally as a tablet or a capsule. Tablets, softgels, geltabs, capsules, liquid and sustained release formulations may beformulated and prepared according to manufacturing techniques well knownin the pharmaceutical industry and in a variety of dosage forms“Administering” a composition may be accomplished by oraladministration, parenteral administration, or by either method incombination with other known techniques.

The term “animal,” “patient,” or “subject” as used herein includes, butis not limited to, humans and non-human vertebrates such as wild,domestic and farm animals. Preferably, the term refers to humans.

The term “inhibiting” includes the administration of a compound of thepresent invention to prevent the onset of the symptoms, alleviate thesymptoms, not worsen the symptoms or eliminate the disease, condition,disorder or a symptom or symptoms thereof.

By “pharmaceutically acceptable”, it is meant the carrier, diluent orexcipient must be compatible with the other ingredients of theformulation and not deleterious to the recipient thereof.

As used herein, the term “therapeutic” means an agent utilized todiscourage, combat, ameliorate, prevent or improve an unwantedcondition, disease or symptom of a patient. In part, embodiments of thepresent disclosure are directed to promoting weight loss, treating andpreventing obesity and obesity related conditions.

A “therapeutically effective amount” or “effective amount” of acomposition is a predetermined amount calculated to achieve the desiredeffect, i.e., to supplement, promote, or increase nutritional health.The activity contemplated by the present methods includes boththerapeutic and/or prophylactic treatment, as appropriate. The specificdose administered according to this disclosure to obtain therapeuticand/or prophylactic effects will, of course, be determined by theparticular circumstances surrounding the case, including, for example,the formulation administered, the route of administration, and thecondition (e.g. weight loss, weight gain, weight management, obesity,insulin resistance) being treated. In some embodiments, the effectiveamount administered may be determined by the physician in the light ofthe relevant circumstances including the condition to be treated, thechoice of compound to be administered, and the chosen route ofadministration. A therapeutically effective amount of compound of thisinvention is typically an amount such that when it is administered in aphysiologically tolerable excipient composition, it is sufficient toachieve an effective systemic concentration or local concentration inthe target tissue.

The terms “ameliorate,” “improve,” or “promote” as used herein refers toboth therapeutic treatment and prophylactic or preventative measures,wherein the object is to prevent or slow down (lessen) an undesiredphysiological condition, disorder or disease, or to obtain beneficial ordesired clinical results. For the purposes of this invention, beneficialor desired clinical results include, but are not limited to, alleviationof symptoms of the condition, disorder or disease; diminishment of theextent of the condition, disorder or disease; stabilization (i.e., notworsening) of the state of the condition, disorder or disease; maintainthe condition, disorder or disease; delay in onset or slowing of theprogression of the condition, disorder or disease; and remission(whether partial or total), whether detectable or undetectable, orenhancement or improvement of the condition, disorder or disease.Examples of beneficial or desired clinical results may include, withoutlimitation, treatment and alleviation of insulin resistance, treatmentof obesity, reduction in weight, prevention of weight gain, fat loss,reduction of hunger and cravings, and stabilization and optimization ofinsulin levels. The terms may further be used to convey that the diseaseor condition is not worsened by administration of the weight losscomposition of embodiments herein. Amelioration or promotion includeseliciting a clinically significant response without excessive levels ofside effects.

In embodiments or claims where the term “comprising” is used as thetransition phrase, such embodiments can also be envisioned withreplacement of the term “comprising” with the terms “consisting of” or“consisting essentially of.”

As used herein, the term “consists of” or “consisting of” means that theformulation includes only the elements, steps, or ingredientsspecifically recited in the particular claimed embodiment or claim.

As used herein, the term “consisting essentially of” or “consistsessentially of” means that the only active ingredient(s) in theformulation or method that treats the specified condition (e.g. nutrientdepletion) is the specifically recited therapeutic(s) in the particularembodiment or claim.

In some aspects, the invention is directed to a weight loss compositionas disclosed in embodiments below, or an effective amount of a weightloss composition, as disclosed in embodiments below.

This application relates generally to weight loss and, moreparticularly, to methods and systems of administering weight lossprograms. Obesity is a significant health risk and can cause and/orcontribute to a number of obesity-related conditions, such ashypertension, lipid disease, type two diabetes, cancer, orthopedicconditions, and other diseases. The treatment of such obesity-relatedconditions can often be expensive over the course of the person's life.

Treatment of obese or overweight individuals can include improved dietand physical exercise. However, efforts to diet and exercise are notsuccessful for everyone. Sedentary lifestyles, ready availability ofpoor dietary choices, genetic risk factors, and stress all can make itdifficult to lose unwanted weight. Medication has offered avenues tolose weight by, for example, reducing the absorption of fat that hasbeen ingested in the diet. However, drug treatments may only result inmodest weight reduction, can include deleterious side effects, and maynot have a beneficial effect on the long-term issues related toincreased weight e.g., diabetes, cardiovascular disease, etc.

Some individuals opt for surgery to lose weight by, for example,reducing the size of the stomach or reducing the length of the bowels.However, complications from surgery are frequent and behaviormodification is needed to enhance the likelihood of a successfuloutcome.

Weight loss compositions are one method of weight reduction used byindividuals regardless of weight classification. Numerous types ofsupplements exist affecting different factors related to weight loss.Certain supplements are aimed at, for example, appetite suppression,decreased nutrient absorption, or increased metabolism. However, thesesupplements often pose potential problems and harmful side effects oftheir own. Supplements intended for reducing appetite may not work asintended because the neural basis of appetite is not fully understood.Supplements for blocking absorption of dietary fats may cause oilystools, stomach pain, and flatulence. Supplements containing activeingredients that stimulate the central nervous system can carry a riskof high blood pressure, faster heart rate, palpitations, closed-angleglaucoma, drug addiction, restlessness, agitation, and insomnia.

There is thus a great need for a weight loss composition thatfacilitates fat burning and/or weight loss, while decreasing the sideeffects known to be associated with other weight loss methods andcompositions. Additionally, there is a need for a weight losscomposition that will take a more holistic approach to weight loss,targeting different obesity promoting mechanisms, to achieve asynergistic weight loss effect in subjects.

Some embodiments herein are directed to a weight loss composition thatincludes a mood enhancer, an insulin sparing agent, and a peripheralenergy blocker. It is believed that the use of a mood enhancer, includedin a weight loss program, may increase endurance and diminish fatigue aswell as a heighten the sense of emotional and mental wellbeing, whichwould help a subject be more inclined to begin, and adhere to, anexercise and diet program. A peripheral energy blocker, included inembodiments herein, is believed to prevent the digestion of excess fatand refined carbohydrates in the diet, thereby allowing it to passthrough their systems without getting absorbed. The use of an insulinsparing agent in a weight loss program may help to lower insulin levels.Insulin has several different effects that lead to fat accumulation inadipose tissue. For example, insulin: (1) promotes fat synthesis; (2)increases the utilization of glucose, which automatically decreases theutilization of fat; (3) inhibits the action of hormone-sensitive lipase,thereby preventing break down of fat and promoting fat storage.

Fat cells have historically been accredited with two main functions,namely that of storing energy and preserving body temperature viainsulation. In the presence of excess intra-abdominal (visceral) fat,however, fat cells, once filled with fat, also assume a hormonalfunction by manufacturing and releasing various chemical substancescalled inflammatory cytokines, able to mimic or interfere with normalhormonal functions. For reasons not completely understood, some of theseinflammatory cytokines disrupt insulin's role on cellular level (at theinsulin receptor that regulates the glucose portal across the cellmembrane) and render insulin less effective. The medical term for thiscondition is ‘insulin resistance’. To get the same task done as before,the body compensates by producing even more insulin, and insulin levelsrise above the norm.

Because of insulin's obesity-promoting effects, insulin resistance makesone more prone to gaining weight than before. In addition, it also makesit more difficult for one to lose weight. Once this condition sets in, avicious cycle begins, explaining why many obese individuals, onceburdened with excess visceral fat, experience that their metabolism haseffectively slowed down.

It is believed that fat breakdown and use of fat to provide energy areenhanced in the absence of insulin. This can occur normally betweenmeals when secretion of insulin is minimal but the effect becomesextreme in diabetes mellitus when secretion of insulin, is almostabsent. When this happens, the aforementioned effects of insulin causingthe production and storage of fat, are reversed. A dominant effect isthat the enzyme hormone-sensitive lipase in the fat cells becomesstrongly activated. This causes hydrolysis of stored triglycerides,releasing large quantities of fatty acids and glycerol from the adiposetissue into the circulating blood. The net effect is significantweight-loss.

Weight Loss Composition

The weight loss composition of embodiments herein are a combination ofnaturally derived plant extracts that display complementary andsynergistic pharmaceutical effects as well as minerals, all of whichresult in the treatment or alleviation of insulin resistance, andoptimization of catabolic metabolism by lowering insulin levels andincreasing the usage of fat for energy purposes, thereby assisting withweight loss.

Some embodiments herein are directed to a weight loss compositioncomprising a Rhodiola root extract, a banaba leaf extract, and an applefruit extract. In some embodiments, the weight loss composition mayfurther include at least one or more of the following: zinc, magnesium,berberine, inositol, Salacia extract, gardenia fruit extract, andchromium. In some embodiments, the zinc, magnesium, and/or chromium arein chelated form.

In some embodiments, the Rhodiola root extract may include rosavin,rosarian, rosin, and salidroside. In some embodiments, the Rhodiola rootextract could be derived from Rhodiola rosea. In some embodiments, theweight loss composition may comprise rosavin in an amount of up to about5%, up to about 4%, up to about 3%, or a value within these ranges. Insome embodiments, the weight loss composition may comprise salidrosidein an amount of up to about 2%, up to 1%, or a value within theseranges. In some embodiments, the Rhodiola root extract is in an amountof about 100 mg/day to about 500 mg/day, about 100 mg/day to about 400mg/day, about 100 mg/day to about 350 mg/day, about 100 mg/day to about340 mg/day, about 140 mg/day to about 500 mg/day, about 140 mg/day toabout 400 mg/day, about 140 mg/day to about 350 mg/day, about 140 mg/dayto about 340 mg/day, about 200 mg/day to about to about 500 mg/day,about 200 mg/day to about 400 mg/day, about 200 mg/day to about 350mg/day, about 200 mg/day to about 340 mg/day, about 300 mg/day to aboutto about 500 mg/day, about 300 mg/day to about 400 mg/day, about 300mg/day to about 350 mg/day, about 300 mg/day to about 340 mg/day, or avalue within any of these ranges. In some embodiments, the Rhodiola rootextract is in an amount of about 140 mg/day, about 150 mg/day, about 200mg/day, about 300 mg/day, about 340 mg/day, about 350 mg/day, about 400mg/day, about 500 mg/day, or a range between any two of these values.

In some embodiments, the banaba leaf extract may be derived fromLagerstroemia speciosa. In some embodiments, the banaba leaf extract maycomprise corosolic acid. In some embodiments, the weight losscomposition may comprise corosolic acid rather than banaba leaf extract.In some embodiments, the corosolic acid (either in the banaba leafextract or as an ingredient of the weight loss composition) may be in anamount of greater than about 2%, about 2% to about 30%, about 2% toabout 25%, about 2% to about 20%, about 2% to about 18%. In someembodiments, the corosolic acid (either in the banaba leaf extract or asan ingredient of the weight loss composition) may be in an amount ofabout 2%, about 5%, about 10%, about 15%, to about 20%, about 25%, about16%, about 17%, about 18%, or a range between any two of these values.In some embodiments, the corosolic acid may be in an amount of about 5mg/day to about 50 mg/day, about 5 mg/day to about 40 mg/day, about 5mg/day to about 30 mg/day, about 5 mg/day to about 20 mg/day, about 5mg/day to about 10 mg/day, about 10 mg/day to about 50 mg/day, about 10mg/day to about 40 mg/day, about 10 mg/day to about 30 mg/day, about 10mg/day to about 20 mg/day, or a value within this range. In someembodiments, the corosolic acid may be in an amount selected from about5 mg/day, about 10 mg/day, about 15 mg/day, about 20 mg/day, or a rangebetween any two of these values. In some embodiments, the banaba leafextract may be in an amount of about 10 mg/day to about 100 mg/day,about 10 mg/day to about 75 mg/day, about 10 mg/day to about 60 mg/day,about 20 mg/day to about 100 mg/day, about 20 mg/day to about 75 mg/day,about 20 mg/day to about 60 mg/day, about 40 mg/day to about 100 mg/day,about 40 mg/day to about 75 mg/day, about 40 mg/day to about 60 mg/day,or a value within these ranges. In some embodiments, the banaba leafextract may be in an amount of about 10 mg/day, about 20 mg/day, about30 mg/day, about 40 mg/day, about 56 mg/day, about 60 mg/day, about 75mg/day, about 100 mg/day, or a range between any two of these values.

In some embodiments, the apple fruit extract may be derived from Malusdomestica. In some embodiments, the apple fruit extract may includegreater than about 30% polyphenols, about 30% to about 99% polyphenols,about 30% to about 90% polyphenols, about 30% to about 80% polyphenols,about 30% to about 75% polyphenols, about 40% to about 90% polyphenols,about 40% to about 80% polyphenols, about 40% to about 75% polyphenols,about 50% to about 90% polyphenols, about 50% to about 80% polyphenols,about 50% to about 75% polyphenols, or a value within any of theseranges. In some embodiments, the apple fruit extract may includepolyphenols in an amount of about 30%, about 40%, about 50%, about 60%,about 75%, about 80%, about 90%, about 99%, or a range between any twoof these values. The apple fruit extract may be in an amount greaterthan 30 mg/day, about 30 mg/day to about 100 mg/day, about 30 mg/day toabout 75 mg/day, about 30 mg/day to about 50 mg/day, about 30 mg/day toabout 45 mg/day, about 40 mg/day to about 100 mg/day, about 40 mg/day toabout 75 mg/day, about 40 mg/day to about 50 mg/day, about 40 mg/day toabout 45 mg/day, or a value within any of these ranges. In someembodiments, the apple fruit extract may be in an amount of about 35mg/day, about 40 mg/day, about 45 mg/day, about 50 mg/day, about 60mg/day, about 70 mg/day, about 80 mg/day, about 90 mg/day, about 100mg/day, or a range between any two of these values.

In some embodiments, the zinc may be in a chelated form, for example, aszinc biglycinate chelate, zinc gluconate, zinc citrate, zinc picolinate,zinc methionate, zinc orotate, or the like. In some embodiments, thezinc chelate is zinc biglycinate chelate, such as that sold under thetrade name TRAACS®. In some embodiments, the elemental zinc may be in anamount greater than about 15 mg/day, about 5 mg/day to about 40 mg/day.In some embodiments, the elemental zinc may be in an amount of about 5mg/day to about 35 mg/day, about 5 mg/day to about 30 mg/day, about 10mg/day to about 50 mg/day, about 10 mg/day to about 45 mg/day, about 10mg/day to about 40 mg/day, about 10 mg/day to about 35 mg/day, about 10mg/day to about 30 mg/day, or a value between any of these ranges. Insome embodiments, the elemental zinc may be in an amount of about 5mg/day, about 10 mg/day, about 15 mg/day, about 20 mg/day, about 25mg/day, about 30 mg/day, about 35 mg/day, about 40 mg/day, or a rangebetween any two of these values.

In some embodiments, the magnesium may be in a chelated form, forexample, as magnesium glycinate, magnesium malate, magnesium taurate,magnesium orotate, magnesium lysinate, dimagnesium malate, or the like.In some embodiments, the magnesium may be dimagnesium malate, such asthat sold under the trade name Albion®. In some embodiments, theelemental magnesium may be in an amount of about 5 mg/day to about 100mg/day, about 5 mg/day to about 75 mg/day, about 5 mg/day to about 50mg/day, about 5 mg/day to about 45 mg/day, about 10 mg/day to about 100mg/day, about 10 mg/day to about 75 mg/day, about 10 mg/day to about 50mg/day, about 10 mg/day to about 45 mg/day, or a value between any ofthese ranges. In some embodiments, the elemental magnesium may be in anamount of about 5 mg/day, about 10 mg/day, about 15 mg/day, about 20mg/day, about 25 mg/day, about 30 mg/day, about 35 mg/day, about 40mg/day, about 45 mg/day, about 50 mg/day, about 55 mg/day, about 60mg/day, about 65 mg/day, about 70 mg/day, about 75 mg/day, about 80mg/day, about 90 mg/day, about 100 mg/day, or a range between any two ofthese values.

In some embodiments, the chromium may be in a chelated form, such aschromium glycinate, chromium nicotinate, chromium nicotinate glycinate,chromium picolinate, chromium GTF (glucose tolerance factor) chelate,chromium polynicotinate, or the like. In some embodiments, the chromiummay be chromium nicotinate glycinate, such as that sold under the tradename TRAACS®. In some embodiments, the elemental chromium may be in anamount of about 100 mcg/day to about 300 mcg/day, about 100 mcg/day toabout 250 mcg/day, about 100 mcg/day to about 210 mcg/day, about 125mcg/day to about 300 mcg/day, about 125 mcg/day to about 250 mcg/day,about 125 mcg/day to about 210 mcg/day, about 150 mcg/day to about 300mcg/day, about 150 mcg/day to about 250 mcg/day, about 150 mcg/day toabout 210 mcg/day, about 175 mcg/day to about 300 mcg/day, about 175mcg/day to about 250 mcg/day, about 175 mcg/day to about 210 mcg/day,about 200 mcg/day to about 300 mcg/day, about 200 mcg/day to about 250mcg/day, about 200 mcg/day to about 210 mcg/day, or a value within oneof these ranges. In some embodiments, the elemental chromium may be inan amount of about 300 mcg/day, about 250 mcg/day, about 210 mcg/day,about 175 mcg/day, about 150 mcg/day, about 125 mcg/day, about 100mcg/day, or a range between any two of these values.

In some embodiments, the Salacia extract may be derived from Salaciareticulata, such as that sold under the trade name Salaretin®. In someembodiments, the Salacia extract may be Salacia bark extract, Salaciaroot extract, Salacia stem extract, or a combination thereof. In someembodiments, the Salacia extract may have an extract ratio of 20:1,15:1, 10:1, 6:1, 5:1, 4:1, or the like. In some embodiments, the Salaciaextract may have an extract ratio of 6:1. In some embodiments, theSalacia extract may be in an amount of about 10 mg/day to about 400mg/day. In some embodiments, the Salacia extract may be in an amount ofabout 10 mg/day to about 300 mg/day, about 10 mg/day to about 200mg/day, about 10 mg/day to about 100 mg/day, about 10 mg/day to about 75mg/day, about 10 mg/day to about 70 mg/day, about 10 mg/day to about 65mg/day, about 10 mg/day to about 60 mg/day, about 10 mg/day to about 55mg/day, about 10 mg/day to about 50 mg/day, about 10 mg/day to about 45mg/day, about 20 mg/day to about 100 mg/day, about 20 mg/day to about 75mg/day, about 20 mg/day to about 50 mg/day, about 20 mg/day to about 45mg/day, or a value selected therefrom. In some embodiments, the Salaciaextract may be in an amount of about 10 mg/day, about 20 mg/day, about30 mg/day, about 35 mg/day, about 40 mg/day, about 45 mg/day, about 50mg/day, about 55 mg/day, about 60 mg/day, about 70 mg/day, about 75mg/day, about 80 mg/day, about 90 mg/day, about 100 mg/day, about 150mg/day, about 200 mg/day, about 250 mg/day, about 300 mg/day, about 350mg/day, about 400 mg/day, or a range between any two of these values.

In some embodiments, the berberine may be berberine hydrochloride. Insome embodiments, the berberine may be derived from Barberry bark androot extract. In some embodiments, the berberine may be derived fromBerberis vulgaris. In some embodiments, the berberine may be derivedfrom Berberis vulgaris, Hydrastis canadensis, Coptis chinensis,Phellodendron amurense, Berberis aristata or a combination thereof. Insome embodiments, the berberine may be in an amount of about 50 mg/dayto about 200 mg/day, about 50 mg/day to about 150 mg/day, about 50mg/day to about 125 mg/day, about 50 mg/day to about 105 mg/day, about75 mg/day to about 200 mg/day, about 75 mg/day to about 150 mg/day,about 75 mg/day to about 125 mg/day, about 75 mg/day to about 105mg/day, about 100 mg/day to about 200 mg/day, about 100 mg/day to about150 mg/day, about 100 mg/day to about 125 mg/day, about 100 mg/day toabout 105 mg/day, or a value within any of these ranges. In someembodiments, the berberine may be in an amount of about 50 mg/day, about75 mg/day, about 100 mg/day, about 105 mg/day, about 115 mg/day, about125 mg/day, about 150 mg/day, about 200 mg/day, or a range between anytwo of these values.

Inositol occurs naturally as phytic acid in the fiber component ofcertain plant foods, and as myo-inositol in meat. In some embodiments,the inositol may be naturally derived. In some embodiments, the inositolmay be manufactured synthetically. It is believed that inositolincreases the action of insulin by improving insulin sensitivity. Insome embodiments, the inositol is in an amount of about 100 mg/day toabout 300 mg/day, about 100 mg/day to about 250 mg/day, about 100 mg/dayto about 210 mg/day, about 125 mg/day to about 300 mg/day, about 125mg/day to about 250 mg/day, about 125 mg/day to about 210 mg/day, about150 mg/day to about 300 mg/day, about 150 mg/day to about 250 mg/day,about 150 mg/day to about 210 mg/day, about 175 mg/day to about 300mg/day, about 175 mg/day to about 250 mg/day, about 175 mg/day to about210 mg/day, about 200 mg/day to about 300 mg/day, about 200 mg/day toabout 250 mg/day, about 200 mg/day to about 210 mg/day, or a valuewithin one of these ranges. In some embodiments, the inositol may be inan amount of about 300 mg/day, about 250 mg/day, about 210 mg/day, about175 mg/day, about 150 mg/day, about 125 mg/day, about 100 mg/day, or arange between any two of these values.

In some embodiments, the gardenia fruit extract is derived from Gardeniajasminoides. In some embodiments, the gardenia fruit extract may have anextract ratio of 20:1, 15:1, 10:1, 6:1, 5:1, 4:1, or the like. In someembodiments, the gardenia fruit extract may have an extract ratio of10:1. In some embodiments, the gardenia fruit extract is in an amount ofabout 25 mg/day to about 200 mg/day, about 25 mg/day to about 150mg/day, about 25 mg/day to about 100 mg/day, about 25 mg/day to about 90mg/day, about 50 mg/day to about 200 mg/day, about 50 mg/day to about150 mg/day, about 50 mg/day to about 100 mg/day, about 50 mg/day toabout 90 mg/day, or a value within any of these ranges. In someembodiments, the gardenia fruit extract is in an amount of about 25mg/day, about 50 mg/day, about 75 mg/day, about 90 mg/day, about 100mg/day, about 125 mg/day, about 150 mg/day, about 175 mg/day, about 200mg/day, or a range between any two of these values.

In some embodiments, the weight loss composition comprises banaba leafextract, apple fruit extract, Rhodiola root extract, magnesium chelate,and zinc chelate. In some embodiments, the weight loss compositioncomprises banaba leaf extract, apple fruit extract, Rhodiola rootextract, gardenia fruit extract, inositol, berberine hydrochloride,Salacia extract, magnesium chelate, zinc chelate, and chromium. In someembodiments, the weight loss composition consists essentially of banabaleaf extract, apple fruit extract, Rhodiola root extract, gardenia fruitextract, inositol, berberine hydrochloride, Salacia extract, magnesiumchelate, zinc chelate, and chromium. In some embodiments, the weightloss composition consists of banaba leaf extract, apple fruit extract,Rhodiola root extract, gardenia fruit extract, inositol, berberinehydrochloride, Salacia extract, magnesium chelate, zinc chelate, andchromium.

In some embodiments, the weight loss composition comprises banaba leafextract in an amount of about 10 mg/day to about 100 mg/day, apple fruitextract in an amount greater than about 30 mg/day, Rhodiola root extractin an amount of about 140 mg/day to about 500 mg/day, magnesium chelatein an amount of about 10 mg/day to about 75 mg/day, and zinc chelate inan amount greater than about 15 mg/day. In some embodiments, the weightloss composition comprises banaba leaf extract in an amount of about 56mg/day, apple fruit extract in an amount of about 45 mg/day, Rhodiolaroot extract in an amount of about 340 mg/day, magnesium chelate in anamount of about 45 mg/day, and zinc chelate in an amount of about 30mg/day. In some embodiments, the weight loss composition comprisesbanaba leaf extract in an amount of about 56 mg/day, apple fruit extractin an amount of about 45 mg/day, Rhodiola root extract in an amount ofabout 340 mg/day, magnesium chelate in an amount of about 45 mg/day,zinc chelate in an amount of about 30 mg/day, berberine hydrochloride inan amount of about 105 mg/day, inositol in an amount of about 210mg/day, Salacia extract in an amount of about 45 mg/day, gardenia fruitextract in an amount of about 90 mg/day, and chromium chelate in anamount of about 210 mcg/day. In some embodiments, the weight losscomposition consists essentially of banaba leaf extract in an amount ofabout 56 mg/day, apple fruit extract in an amount of about 45 mg/day,Rhodiola root extract in an amount of about 340 mg/day, magnesiumchelate in an amount of about 45 mg/day, zinc chelate in an amount ofabout 30 mg/day, berberine hydrochloride in an amount of about 105mg/day, inositol in an amount of about 210 mg/day, Salacia extract in anamount of about 45 mg/day, gardenia fruit extract in an amount of about90 mg/day, and chromium chelate in an amount of about 210 mcg/day. Insome embodiments, the apple fruit extract includes about 75%polyphenols. In some embodiments, the weight loss composition consistsof banaba leaf extract in an amount of about 56 mg/day, apple fruitextract in an amount of about 45 mg/day, Rhodiola root extract in anamount of about 340 mg/day, magnesium chelate in an amount of about 45mg/day, zinc chelate in an amount of about 30 mg/day, berberinehydrochloride in an amount of about 105 mg/day, inositol in an amount ofabout 210 mg/day, Salacia extract in an amount of about 45 mg/day,gardenia fruit extract in an amount of about 90 mg/day, and chromiumchelate in an amount of about 210 mcg/day.

While the amounts of ingredients above have been given in mass units perday, it is conceivable that a weight loss composition may comprise therecited mass units to administered in one unit dosage taken once dailyor divided into multiple unit dosages.

Weight Management Plan

Some embodiments herein are directed to a kit comprising the weight losscompositions of embodiments herein and instructions for a weightmanagement plan. In some embodiments, the instructions may be in theform of a website address, a mobile app, a brochure, chart, a booklet, acombination thereof, or the like. The weight management plan ofembodiments herein focuses on whole foods and on feeding the bodynutritious foods which are low in preservatives and additives and whichare not necessarily low in fat or calories. The intention is to controlsatiety and to sustain energy while energizing the metabolism. Theweight management plan of embodiments herein are also designed to ensurethat a subject consumes balanced meals which include food selected fromeach food category i.e. protein, fat, carbohydrates (such as fromstarches and fruit), and vegetables to optimize insulin effects and tomaximize energy while causing the body to burn fat without anymeaningful muscle loss. In some embodiments, the weight management plancomprises:

(1) establishing a food index which includes four main categories offood, namely vegetables, proteins, carbohydrates (including fromstarches and fruit), and fat, defining a portion for each category andassigning a food value to each respective portion, in units, wherein thefood value is based, at least, on the following parameters: calories,sugar content, fiber content, fat content, and processed content(including additives and processed sugars);

(2) determining a subject's base food allowance, in terms of the units,based at least on one or more of the following parameters of thesubject:

-   -   gender;    -   age;    -   height;    -   BMI;    -   weight; and    -   life activity;

(3) establishing an activity index, which includes a variety ofexercises that could be performed by a subject, defined in terms of atime interval for which the exercise is performed, and assigning avalue, in the units, to each time interval;

(4) determining, for the subject, a daily food allowance, in the units,as the sum of the base food allowance and values obtained from theactivity index due to corresponding activities that are listed in theactivity index being performed by the subject, and

(5) allowing the subject to choose, from the food index, portions offoods for consumption, wherein the sum of the food values of the chosenportions of foods is in a predetermined relationship to the daily foodallowance. In some embodiments, the sum of the food values of the chosenportion of food should not vary from the daily food allowance by morethan 10%. In some embodiments, at least one food portion is selectedfrom each food category for each meal; and at least three meals areconsumed each day.

The following formula may be used to provide a rough estimate of aparticular food's food value: for a given amount of food, i.e. a portionexpressed in a conventional measurement unit (e.g. a cup, an ounce, atablespoon, milliliters, grams, or the like), the following assessmentsare made:

a base energy value (B) is determined by dividing the calorie value ofthe food portion by a factor of 2.7 to 3;

the following values are established in grams;

-   -   a. fiber content (F);    -   b. protein content (P);    -   c. sugar content (S);    -   d. fat content (FT); and    -   e. processed content (PC).

The food value for the chosen portion is established by subtracting thepositive values items (fiber and protein) from the base energy value andby adding the negative value items (sugar, fat and processed content) tothe base energy value, as follows:

B−F−P+S+FT+PC=FV

The subject's base food allowance, determined in step (2), is preferablylinked to the quantity of food a subject can consume each day, beforeexercise, to lose between one and two pounds of fat weight per week.

The food categories used in the weight management plan may includevegetables, protein, carbohydrates (which includes starches and fruit)and fat. The plan requires the inclusion of at least one portion of eachfood group in each meal and promotes the consumption of three meals aday using all four food groups, with snacks, as may be appropriate.

As an example, a single bagel and a glass of orange juice equate to 300food value units, and represent approximately one and a half times theglucose and insulin loads which would be created by the consumption oftwo eggs, a slice of toast, a ½ cup of fruit, a cup of vegetables andone teaspoon of real butter (±175 food value units).

A subject who ate the bagel and juice would have an insulin spike whichresults in an increase in fat storage but there would be no protein orfat consumption. Energy levels would rapidly decline within about twohours resulting in a reduction in the metabolism rate and this wouldcreate a need for food and sugar. The alternative food consumptionproposed by embodiments of the weight management plan would allow thesubject to produce less glucose and insulin. Excess glucose would not bestored as fat. In response to the ingestion of the alternative foods(eggs, toast, fruit etc.) the body would accelerate the metabolic rate,and would seek energy reserves from stored food. Satiety and high energylevels would be maintained for three to four hours or until legitimatehunger pangs again arose.

In some embodiments, the weight loss composition is designed to be takenwith a meal. In some embodiments, the weight loss composition isdesigned to be taken before a meal. In some embodiments, the weight losscomposition is designed to be taken before a meal by about 15 minutes toabout 120 minutes, about 15 minutes to about 90 minutes, about 15minutes to about 60 minutes, about 15 minutes to about 45 minutes, about15 minutes to about 30 minutes, about 30 minutes to about 120 minutes,about 30 minutes to about 90 minutes, about 30 minutes to about 60minutes, about 30 minutes to about 45 minutes, or a value within any ofthese ranges.

Bulk Food Product

Some embodiments herein are directed to a bulk food product. Someembodiments herein are directed to a kit comprising a bulk food productof embodiments herein and the weight loss composition of embodimentsherein. Embodiments are also directed to a kit comprising the bulk foodproduct of embodiments herein, instructions for the weight loss plan ofembodiments herein, and the weight loss composition of embodimentsherein.

In some embodiments, the bulk food product may comprise a plurality ofmeal portions, each meal portion comprising protein, fat, carbohydratesfrom a starch source, carbohydrate from a non-starch vegetable source,and fiber. In some embodiments, each meal portion may further comprise aphyto blend comprising an ingredient selected from mushroom powder,moringa leaf extract, ginger, turmeric, saffron, a natural supplementblend, digestive enzymes, probiotics (e.g. Bacillus subtilis or B.coagulans), fruits, vegetables, herbs, or a combination thereof.

The protein may be obtained from food sources known to be high inprotein. Specifically, the protein source may be selected from leanmeat, such as chicken without skin, beef, pork and fish. Alternatively,the protein source may be selected from a variety of beans to create avegetarian-friendly bulk food product.

The carbohydrate from the non-starch vegetable source may be obtainedfrom any vegetable source including, but not limited to, carrot, spinachand other non-starch vegetables.

The carbohydrate from the starch source may be obtained from any starchsource including, but not limited to, potatoes, rice and yams (or sweetpotato).

The phyto blend may include a selection of natural plant based foods,such as wheat grass, flax, wheat germ and other ingredients high innutrition and fiber. The phyto blend may also include enzymes andprobiotics that are conducive to health. In some embodiments, the phytoblend may comprise at least one of mushroom powder, moringa leafextract, ginger, turmeric, saffron, a natural supplement blend,digestive enzymes, probiotics (e.g. Bacillus subtilis or B. coagulans),fruits, vegetables, and herbs. In some embodiments, the ginger is aginger rhizome. In some embodiments, the turmeric is turmeric rhizome.In some embodiments, the phyto blend may comprise the ingredients setout in Table 1.

TABLE 1 PHYTO BLEND Amount Per Serving Dosage/day Fruit, vegetable,cereal 500 mg grass, herbal, and phytonutrient blend Reishi (Ganoderma250 mg lucidum) mycelial biomass powder Shiitake (Lentinus edodes) 250mg mycelial biomass powder Moringa (Moringa 500 mg oleifera) leafextract (10:1 or TBD) Bacillus subtilis* 50 mg Bacillus coagulans*133.33 mg Saffron (Crocus sativus) 30 mg stigma extract [standardized to0.2% safranal] Ginger (Zingiber 200 mg officinale) rhizome powderTurmeric (Curcuma longa) 500 mg rhizome powder *B. subtilis = 5billion/cfu/day; B. coagulans = 2 billion/cfu/day

In some embodiments, the natural supplement blend may be selected from afruit, vegetable, cereal grass, herbal, and phytonutrient blend, such asthat sold under the tradename Spectra™ or Amazing Grass® GreenSuperfood®. The natural supplement may be in an amount of about 100 mgto about 1000 mg, about 200 mg to about 1000 mg, about 300 mg to about1000 mg, about 400 mg to about 1000 mg, about 500 mg to about 1000 mg,about 100 mg to about 500 mg, about 200 mg to about 500 mg, about 300 mgto about 500 mg, about 400 mg to about 500 mg, or a value within any ofthese ranges. The natural supplement may be in an amount of about 100mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600mg, about 700 mg, about 800 mg, about 900 mg, about 1000 mg, or a rangeof any two of these values.

In some embodiments, the mushroom powder may comprise any type ofmushroom. In some embodiments, the mushroom powder may comprise reishimushroom, shiitake mushrooms, or a combination thereof. In someembodiments, the mushroom powder may be in an amount of about 100 mg toabout 1000 mg, about 200 mg to about 1000 mg, about 300 mg to about 1000mg, about 400 mg to about 1000 mg, about 500 mg to about 1000 mg, about100 mg to about 500 mg, about 200 mg to about 500 mg, about 300 mg toabout 500 mg, about 400 mg to about 500 mg, or a value within any ofthese ranges. The mushroom powder may be in an amount of about 100 mg,about 200 mg, about 300 mg, about 400 mg, about 500 mg, about 600 mg,about 700 mg, about 800 mg, about 900 mg, about 1000 mg, or a range ofany two of these values.

In some embodiments, the moringa leaf extract may have an extract ratioof about 20:1, about 15:1, about 10:1, about 6:1, about 5:1, about 4:1,or the like. In some embodiments, the extract ratio is about 10:1. Insome embodiments, the mushroom powder may be in an amount of about 100mg to about 1000 mg, about 200 mg to about 1000 mg, about 300 mg toabout 1000 mg, about 400 mg to about 1000 mg, about 500 mg to about 1000mg, about 100 mg to about 500 mg, about 200 mg to about 500 mg, about300 mg to about 500 mg, about 400 mg to about 500 mg, or a value withinany of these ranges. The moringa leaf extract may be in an amount ofabout 100 mg, about 200 mg, about 300 mg, about 400 mg, about 500 mg,about 600 mg, about 700 mg, about 800 mg, about 900 mg, about 1000 mg,or a range of any two of these values.

The saffron stigma extract may be derived with Crocus sativus. In someembodiments, the saffron stigma extract is in an amount of about 5 mg toabout 60 mg, about 10 mg to about 60 mg, about 15 mg to about 60 mg,about 20 mg to about 60 mg, about 25 mg to about 60 mg, about 30 mg toabout 60 mg, about 5 mg to about 45 mg, about 10 mg to about 45 mg,about 15 mg to about 45 mg, about 20 mg to about 45 mg, about 25 mg toabout 45 mg, about 30 mg to about 45 mg, about 5 mg to about 30 mg,about 10 mg to about 30 mg, about 15 mg to about 30 mg, about 20 mg toabout 30 mg, about 25 mg to about 30 mg, or a value in any of theranges. In some embodiments, the saffron stigma extract is in an amountof about 5 mg, about 10 mg, about 15 mg, about 20 mg, about 25 mg, about30 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, or a rangebetween any two of these values. In some embodiments, the saffron stigmaextract comprises safranal in an amount of about 0.01% to about 0.3%,about 0.01% to about 0.2%, about 0.05% to about 0.3%, about 0.05% toabout 0.2%, about 0.1% to about 0.2%, about 0.1% to about 0.3%, about0.15% to about 0.2%, about 0.15% to about 0.3%, or a value within any ofthese ranges. In some embodiments, the saffron stigma extract comprisessafranal in an amount of about 0.2%, about 0.1%, about 0.15%, about0.01%, about 0.05%, or a range between any two of these values.

In some embodiments, the ginger rhizome comprises Zingiber officinale.In some embodiments, the ginger rhizome is in an amount of about 1 mg toabout 100 mg, about 5 mg to about 100 mg, about 10 mg to about 100 mg,about 20 mg to about 100 mg, about 30 mg to about 100 mg, about 40 mg toabout 100 mg, about 50 mg to about 100 mg, about 1 mg to about 75 mg,about 5 mg to about 75 mg, about 10 mg to about 75 mg, about 20 mg toabout 75 mg, about 30 mg to about 75 mg, about 40 mg to about 75 mg,about 50 mg to about 75 mg, about 1 mg to about 50 mg, about 5 mg toabout 50 mg, about 10 mg to about 50 mg, about 20 mg to about 50 mg,about 30 mg to about 50 mg, about 40 mg to about 50 mg, about 1 mg toabout 45 mg, about 5 mg to about 45 mg, about 10 mg to about 45 mg,about 20 mg to about 45 mg, about 30 mg to about 45 mg, about 40 mg toabout 45 mg, or a value within any of these ranges. In some embodiments,the ginger rhizome comprises gingerols in an amount of about 0.01% toabout 10%, about 0.1% to about 10%, about 0.5% to about 10%, about 1% toabout 10%, about 2% to about 10%, about 3% to about 10%, about 4% toabout 10%, about 5% to about 10%, 0.01% to about 5%, about 0.1% to about5%, about 0.5% to about 5%, about 1% to about 5%, about 2% to about 5%,about 3% to about 5%, about 4% to about 5%, at least about 5%, at leastabout 1%, or a value within any of these ranges. In some embodiments,the ginger rhizome comprises gingerols in an amount of about 0.01%,about 0.1%, about 0.5%, about 1%, about 2%, about 3%, about 4%, about5%, about 10%, or a range of any of two of these values.

In some embodiments, the turmeric rhizome may be in an amount of about10 mg to about 500 mg, about 25 mg to about 500 mg, about 50 mg to about500 mg, about 75 mg to about 500 mg, about 100 mg to about 500 mg, about10 mg to about 250 mg, about 25 mg to about 250 mg, about 50 mg to about250 mg, about 75 mg to about 250 mg, about 100 mg to about 250 mg, about10 mg to about 100 mg, about 25 mg to about 100 mg, about 50 mg to about100 mg, about 75 mg to about 100 mg, or a value within any of theseranges. In some embodiments, the turmeric rhizome may be in an amount ofabout 10 mg, about 25 mg, about 50 mg, about 75 mg, about 100 mg, about200 mg, about 250 mg, about 300 mg, about 400 mg, about 500 mg, or arange of any two of these values.

In some embodiments, the probiotics is in an amount of about 1 mg toabout 100 mg, about 5 mg to about 100 mg, about 10 mg to about 100 mg,about 20 mg to about 100 mg, about 30 mg to about 100 mg, about 40 mg toabout 100 mg, about 50 mg to about 100 mg, about 1 mg to about 75 mg,about 5 mg to about 75 mg, about 10 mg to about 75 mg, about 20 mg toabout 75 mg, about 30 mg to about 75 mg, about 40 mg to about 75 mg,about 50 mg to about 75 mg, about 1 mg to about 50 mg, about 5 mg toabout 50 mg, about 10 mg to about 50 mg, about 20 mg to about 50 mg,about 30 mg to about 50 mg, about 40 mg to about 50 mg, or a valuewithin any of these ranges. In some embodiments, the probiotics maycomprise a Bacillus (e.g. B. subtilis or B. coagulans), a Lactobacillus(L. acidophilus, L plantarum, or L. reuteri), a Bifidobacterium (e.g. B.animalis, B. breve, B. lactis, B. longum, or B. infantis), aStreptococcus (S. salivarius K12 or S. Salivarius M18), combinationsthereof, or any other probiotic. In some embodiments, the probiotic isin an amount of about 1 million cfu to about 10 million cfu, about 2million cfu to about 10 million cfu, about 3 million cfu to about 10million cfu, about 4 million cfu to about 10 million cfu, about 5million cfu to about 10 million cfu, about 1 million cfu to about 8million cfu, about 2 million cfu to about 8 million cfu, about 3 millioncfu to about 8 million cfu, about 4 million cfu to about 8 million cfu,about 5 million cfu to about 8 million cfu, about 1 million cfu to about5 million cfu, about 2 million cfu to about 5 million cfu, about 3million cfu to about 5 million cfu, about 4 million cfu to about 5million cfu, or a value in any of these ranges. In some embodiments, theprobiotic is in an amount of about 1 million cfu, about 2 million cfu,about 3 million cfu, about 4 million cfu, about 5 million cfu, about 6million cfu, about 7 million cfu, about 8 million cfu, about 9 millioncfu, about 10 million cfu, or a range of any two of these values.

The units above for the phyto blend and the weight loss compositioncomposition may be daily amounts that could be administered as one ormore servings.

The natural preservative blend may include natural ingredients whichpreserve food and provide flavor such as sea salt, lemon, rosemary oil,garlic and other natural flavorings.

The ingredients may be selected to create a variety of different bulkfood products suitable to different tastes e.g. suitable ingredients canbe selected to produce a sweet food product, a savory food product, avegetarian food product, etc. In some embodiments, the bulk food productmay be in a form which may be diluted to create a stew or a soup (suchas a jarred or otherwise packaged concentrate).

The size of a serving is preferably adequate to provide sufficientenergy to support the caloric requirements of a subject for about 3 to 5hours depending on the subject's energy expenditure or objective.

While a meal portion of the bulk food product is flexible, a baselineserving for each meal portion has been established as between about 400g to about 525 g of the bulk food product. This is approximately equalto 400 to 525 calories. In some embodiments, the baseline serving isabout 450 g of the food product which provides approximately 450calories.

In some embodiments, each meal portion includes about 26 g to about 40 gof protein, about 7 g to about 16 g of fat, about 15 g to about 20 g ofcarbohydrate from a starch source, about 20 g to about 30 g ofcarbohydrate from a vegetable source or non-starch source (such as beansand legumes), and about 11 g to about 21 g of fiber. In someembodiments, the meal portion further includes about 1 g to about 10 gof a phyto blend, about 1 g to about 3 g of a natural preservativeblend, or a combination thereof. In some embodiments, each meal portionincludes protein in an amount of about 5% to about 9%, fat in an amountof about 1% to about 4%, carbohydrate from a starch source in an amountof about 3% to about 5%, carbohydrate from a vegetable or non-starchsource in an amount of about 4% to about 7%, and fiber in an amount ofabout 2% to about 5%. In some embodiments, each meal portion may furtherinclude a phyto blend in an amount of about 0.2% to about 2.5%, anatural preservative blend in an amount of about 0.2% to about 0.8%, ora combination thereof.

In some embodiments, the bulk food product may include at least two mealportions, at least three meal portions, at least five meal portions, atleast 7 meal portions, about 2 to about 24 meal portions, about 3 toabout 24 meal portions, about 5 to about 24 meal portions, about 7 toabout 24 meal portions, about 8 to about 24 meal portions, about 14 toabout 24 meal portions, about 21 to about 24 meal portions, about 2 toabout 21 meal portions, about 3 to about 21 meal portions, about 5 toabout 21 meal portions, about 7 to about 21 meal portions, about 8 toabout 21 meal portions, about 14 to about 21 meal portions, or a valuewithin these ranges. In some embodiments,

The bulk food product may be a mixture packaged with at least one scoopor cup, of a defined size, to measure out a meal portion or fractionsthereof. For example, a measuring cup could be provide which measuresout one half of the recommended meal portion of the bulk food product.After packaging, the bulk food product may be snap frozen orrefrigerated.

The food product may be used to implement any type of balanced diet andcan be used for weight loss, weight maintenance or weight gain purposes,or as a snack or meal substitute. For example, the bulk food product maybe used to implement a calorie restricted diet for weight loss, byreducing the amount of the food product which is consumed per meal. Thebulk food product may also be used to implement the weight managementplan of embodiments herein. In some embodiments, the food product may beused, for example by adolescents or athletes, to gain weight healthilyby increasing the size of the portion of the food product, i.e. theamount, consumed per meal. Additional portions may also be consumed assnacks between meals. A side dish, such as an egg or a salad, may beadded as required by a subject. For example, an athlete/bodybuilder maywish to add an extra protein source in the form of an egg etc.

Exemplary benefits of the bulk food product include convenience, ease ofuse, and improved adherence to a nutrition and exercise program, such asthe weight loss plan of embodiments herein. The bulk food productcomprises a plurality of complete balanced meal portions. Each mealportion is associated with a food value that is easy to keep track ofand correlate with the daily base food allowance for the subject in theweight management plan of embodiments herein. Additionally, whenconsuming a meal portion of the bulk food product, the subject isassured that the meal is balanced and contains ingredients selected fromall varieties of foods, categorized in terms of their fiber andessential nutrient content, ensuring that the essential nutrients arepresent in a ratio which is optimal for stabilizing insulin resistance.

The bulk food product and the accompanying weight management planfurther affords the subject freedom to choose when to eat all or a partof his/her daily base food allowance. Additionally, because theresponsibility or discretion placed on the subject to select ingredientsis removed, the bulk food product has a substantial psychologicalbenefit in that the consumer is relieved of the flexibility of choiceand, when eating a complete meal product is inherently assured ofconsuming the appropriate number of food units, containing fiber and thethree essential nutrients in the correct combinations and proportions tofollow the weight management plan of embodiments herein. Additionally,exemplary benefits of the weight loss composition of embodiments herein,as mentioned above, are to normalize insulin levels, control glucose andfat storage, balance hormones, and reduce insulin resistance as well askickstart the metabolism in the subject to help them achieve their idealweight.

Methods

Some embodiments herein are directed to a method of treating orpreventing obesity in a subject comprising administering to the subjectthe weight loss composition of embodiments herein. In some embodiments,the subject concurrently follows a weight management plan of embodimentsherein. In some embodiments, the subject uses the bulk food product ofembodiments herein to at least partly follow the weight management plan.

Some embodiments herein are directed to a method for promoting weightloss in a subject, the method comprising administering to the subjectthe weight loss composition of embodiments herein. In some embodiments,the subject concurrently follows a weight management plan of embodimentsherein. In some embodiments, the subject uses the bulk food product ofembodiments herein to at least partly follow the weight management plan.

Some embodiments herein are directed to a method of improving insulinresistance in a subject, the method comprising administering to thesubject the weight loss composition of embodiments herein. In someembodiments, the subject concurrently follows a weight management planof embodiments herein. In some embodiments, the subject uses the bulkfood product of embodiments herein to at least partly follow the weightmanagement plan.

This invention and embodiments illustrating the method and materialsused may be further understood by reference to the followingnon-limiting examples.

Example 1 Effect of the GOLO Diet (Weight Management Plan) and GOLORelease Supplement (Weight Loss Composition) on Weight, Glycemic Controland Indicators of Insulin Sensitivity in Overweight and Obese Patientswith Type 2 Diabetes

Summary:

26 subjects with type 2 diabetes mellitus were recruited in anopen-label study of the GOLO Diet with Release supplement at a singleclinical site. 15 subjects completed the study over the 13-weektreatment period. Overall weight loss averaged 7.9 lbs (−3.8%) and BMIlevels dropped by 1.3 (−3.7%). Markers of glycemic control improved withHemoglobin A1C (−9.2%) and fasting blood glucose (−17.9%) decreasingwhile markers of insulin resistance including insulin levels (−18.7%)and HOMA-IR (−36.6%) showed substantial improvement. Favorableimprovement was also noted in other laboratory results and clinicalmeasures including cholesterol levels and inflammation.

Introduction:

Excess body weight from overeating, poor nutrition and lack of exerciseis highly correlated with health status. Clinical weight loss inoverweight and obese people is associated with improvements in clinicalmarkers of health, including key measures of blood sugar and bloodlipids used to determine a person's health status

Populations who are overweight and obese include people who exhibit awide range of blood sugar levels, ranging from healthy to pre-diabeticto type 2 diabetes. Overweight and obese people on this spectrum oftenhave difficulty obtaining meaningful or sustained weight loss. Bodyweight is also a leading indicator of high blood sugar levels. It iswell established that people who are healthy, pre-diabetic or diabeticwho lose weight and exercise tend to lower their measures of blood sugarand blood lipids, and are more likely to improve their health status(1).

GOLO has created a weight management program that includes a supplement(weight loss composition) known as Release and (GWMP) and is designed tohelp people who are overweight or obese get the proper balance of macroand micro nutrients from conventional foods, in the proper portions andcombinations to help keep insulin steady for weight loss, and help themto transition to a healthier lifestyle. The GWMP includes a point-basedsystem from the four macronutrient food groups that is based on theindividual's activity level and body mass. Additionally, the programincludes common-sense instructions, motivation and tips supportingcompliance and recommends a minimum of 15 minutes of exercise per day.The Release dietary supplement contains 7 plant based ingredients and 3minerals including zinc and chromium, essential nutrients that supportregulation of blood sugar.

In case studies from clinician and wellness program use, GWMP has shownthe ability to reduce body weight in both healthy and diabetic peoplewho are overweight or obese. Secondary endpoints including measures ofblood sugar have been observed to decrease as a result of the GWMPprogram (2).

While the GWMP has been developed and used in private clinical practicein both healthy overweight and type 2 diabetic people, more systematicresearch is needed to determine to what extent it is able to supporthealthy weight loss. This open-label pilot study is intended to observethe effects of the program in a representative group of subjects withstable type 2 diabetes at one outpatient medical practice.

Study Design:

This observational study evaluating the effect of the GOLO WeightManagement Program (GWMP) on weight and metabolic syndrome indicators inoverweight or obese subjects with stable type 2 diabetes mellitus wasconducted at one clinical site in the United States. The study consistedof 4 visits over approximately 13 weeks.

At visit 1, study eligibility was determined and subjects were given thecommercially available GOLO Weight Management Program and instructed onthe program's diet and exercise guidelines. Subjects were given theRelease Supplement and instructed to take one capsule three times a daywith meals. Laboratory and body measurements were obtained. Visit 2 wasa telephone call to subjects to assess tolerability of the program. Atapproximately week 4, subjects returned for Visit 3 for a compliance andtolerability assessment and body measurements. The final visit 4occurred at approximately week 13 and included body measurements,laboratory analysis and compliance and tolerability assessment.

Body measurements included fasting weight, height, waist and hipcircumference, and resting blood pressure and pulse were taken at eachvisit. A Tanita scale was used to calculate BMI, body fat and visceralfat. Laboratory evaluation included hemoglobin A1C, fasting insulin,fasting blood glucose, lipid panel, metabolic panel including livertesting, hsCRP, CBC, sex hormones, and PSA in men. Homeostatic modelassessment of insulin resistance HOMA-IR was calculated using theformula (Fasting Blood Glucose) (Fasting Insulin)/22.5(3). Stress andAnxiety were measured at visit 1 and visit 4 using a standardized StressQuestionnaire.

Subjects:

26 subjects consented to participate in the study. One subject screenfailed for a BMI outside of inclusion criteria. 10 subjects withdrew orwere removed from the study for the following reasons: 5 lost tofollow-up/voluntarily withdrew, 3 adverse events and 2 poor studycompliance. 15 subjects completed the study and attended all 4 visits.

Results:

5 Males and 10 Females completed the study. The average age of males was57.8 and females 58.5. The average starting weight was 206.3 pounds andBMI 34.3 which is considered obese. Average hemoglobin A1c (7.5) andfasting blood glucose (153.7) were elevated at baseline indicatingpoorly controlled type 2 DM. Initial resting blood pressure (124.1/75.5)and LDL cholesterol (100.5) were already at or near goal levels in thisgroup of diabetic subjects, primarily due to pre-study treatment withblood pressure and cholesterol medications.

Changes from baseline visit 1 to visit 4 in weight, BMI, body analysisand body measurements are listed in Table 2. Overall weight lossaveraged 7.9 lbs (−3.8%) and BMI levels dropped by 1.3 (−3.7%). Loss ofFat Mass (−7.2%) were more pronounced in this overweight/obesepopulation. Waist measurements (−6.1%) improved more than hipmeasurements (−3.5%) resulting in a favorable change in waist/hip ratio(−6.1%). Changes in resting blood pressure and pulse were minimal as themajority of subjects were treated with blood pressure medication as isstandard care in diabetic patients. Changes in the Stress/Anxiety surveywere substantial (−49.0%).

TABLE 2 CHANGES IN WEIGHT AND BODY MEASUREMENTS Visit 1 Visit 4 (Week 1)(Week 13) Change Weight (lbs.) 206.3 198.4 −7.9 (−3.8%) BMI 34.3 33 −1.3(−3.7%) Fat Mass (lbs.) 77.7 72.1 −5.6 (−7.2%) Visceral Fat Rating 13.812.8 −1.0 (−7.2%) Waist (cm) 113.6 106.7 −6.9 (−6.1%) Hips (cm) 115 111−4.0 (−3.5%) Waist/Hip Ratio 1.77 1.66 −0.1 (−6.1%) Stress/Anxiety Score10.5 5.3  −5.1 (−49.0%)

Changes from baseline visit 1 to visit 4 in markers of glycemic controland insulin sensitivity are listed in Table 3. Levels of Hemoglobin A1C(−9.2%), a measurement of DM control over a 3-month period improvedwhile fasting blood glucose improvement was even more pronounced(−17.9%). Markers of insulin resistance, an important cause of type 2 DMand other diseases, decreased greatly with insulin levels falling(−18.7%) and HOMA-IR, a standard calculation of insulin resistance,dropping even more extensively (−36.6%).

TABLE 3 CHANGES IN MARKERS OF GLYCEMIC CONTROL AND INSULIN RESISTANCEVisit 1 Visit 4 (Week 1) (Week 13) Change Hemoglobin A1C 7.5 6.8 −0.7(−9.2%) Insulin Level 15.8 12.8  −3.0 (−18.7%) (uIU/ml) Fasting Glucose153.7 126.3 −27.5 (−17.9%) (mg/dl) HOMA-IR 6.5 4.1  −2.4 (−36.6%)

Changes from baseline visit 1 to visit 4 in total and LDL cholesterollevels were minimal but favorable in this group of subjects thatgenerally were already being treated with statin medications. (Table 4)Improvements in HDL levels were more substantial (3.4%) as wereimprovements in triglyceride levels (−12.1%). Levels of hsCRP a markerof general inflammation and associated with cardiovascular risk werereduced (−2.8%).

TABLE 4 CHANGES IN LIPID PANEL Visit 1 Visit 4 (Week 1) (Week 13) ChangeTotal Cholesterol 179.1 177.2 −1.9 (−1.0%) (mg/dl) LDL Cholesterol 100.599.8 −0.7 (−0.7%) (mg/dl) HDL Cholesterol 43.7 45.2 1.5 (3.4%) (mg/dl)Triglycerides 183.1 161.0 −22.1 (−12.1%) hsCRP 5.5 5.3 −0.2 (−2.8%)

Discussion:

Among the 15 subjects completing this study, weight loss wasdemonstrated and averaged 7.9 pounds over 13 weeks. This weight loss isimpressive because treatments for type 2 DM often are associated withweight gain. One explanation for this usual weight gain is that as bloodsugar control is improved with intervention, less glucose is generallylost through renal oversaturation (glycosuria), retaining thesecalories, and weight gain is often seen initially with diabetictreatments. Generally, any weight loss achieved in the first 3 months ofdiabetes treatment is considered important. In addition, thepreferential loss of fat mass as demonstrated in this study isparticularly desirable in treating type 2 DM.

Improvements in glycemic control and insulin resistance were the mostimpressive results of the study. Hemoglobin A1C and fasting bloodglucose over 13 weeks compares favorably with traditional oralanti-diabetic treatments like metformin or pioglitazone. While theinitial average A1C at baseline (7.5) indicated poor diabetic control,the average A1C level at V4 (6.8) met the goal A1C level recommended fordiabetic patients (less than 7.0). Changes in fasting insulin level andHOMA-IR actually exceeded that seen with these prescribed medications.The large improvements in insulin resistance demonstrated by the GWMPsystem with the Release supplement suggest a beneficial role in otherdisease states including the Metabolic Syndrome.

Favorable changes to other laboratory tests were observed from baselinevisit 1 to visit 4 and are listed in Table 5. Improvement in livertransaminase enzymes (AST and ALT) are often seen with weight loss andmost likely reflect decreased inflammation from fatty liver. Changes insex hormones are also seen following weight loss and represent decreaseperipheral fat conversion of hormone pre-cursers and suggest a benefitin patients with Polycystic Ovary Disease (PCOS). No other significantchanges in metabolic panel values, PSA or other safety variables wereobserved. Three subjects terminated from the study due togastrointestinal adverse events including loose bowel movements orabdominal cramps. No serious adverse events were identified.

TABLE 5 CHANGES IN LIVER TRANSAMINASES AND SEX HORMONES Visit 1 Visit 4(Week 1) (Week 13) Change AST (mg/dl) 28.2 24.7 −3.5 (−12.3%) ALT(mg/dl) 34.4 29.9 −4.5 (−13.0%) Progesterone 1.1 .3 −0.8 (−76.9%)(women) Estradiol (women) 34.4 24.8 −9.6 (−27.9%)

The Stress/Anxiety questionnaire was a 20-question self-administeredwritten test that served as a general marker of psychological health.Although the study was not statistically powered for this endpoint, thechange in average score on this questionnaire was impressive (−49%) andsuggest the opportunity for further study.

The study was limited by selection of subjects at only one clinicalsite. In addition, the study was open-label and lacks the rigor of adouble-blinded placebo-controlled study. In addition, poor subjectcompliance with the GWMP diet and exercise component may also haveinfluenced the results of the study. Although compliance with theRelease supplement as obtained by pill counts (95 percent overallcompliance by pill count) was excellent, compliance with diet andexercise recommendations was variable and more difficult to quantify.The relatively high drop-out rate (10/25-40%) of the subjects consentedfor the study reflect this difficulty in obtaining compliance with theprogram. Frustration with previous diet plans and unrealisticexpectations about lifestyle change likely contributed to drop outs. Inaddition, enrolling a population with type 2 diabetes that likely hasfailed other attempts at diet, exercise and medical therapy presentedchallenges to compliance.

In summary, the GOLO Weight Management Program with the Releasesupplement demonstrated weight loss and improvement in glycemic controlcomparable to standard prescription anti-diabetic medications in thissmall, single center study. Improvements in markers of insulinresistance were impressive and exceeded those seen by existinganti-diabetic medications including the Gold Standard for treatment ofinsulin resistance pioglitazone. Further studies will be needed toevaluate the role of the GOLO Weight Management Program with the Releasesupplement in diabetic and non-diabetic populations.

Example 2

Efficacy of a Diet Program on Body Weight in Overweight and Obese SouthAfricans

Background

Over the course of several years the Medical Nutritional Institute (MNI)based in Johannesburg South Africa developed a weight loss program tohelp combat obesity and weight related conditions. The program includeda lifestyle change plan, meal plan and dietary supplement labeled asAntagolin.

Five studies were conducted in South Africa, in Cape Town andJohannesburg during 2009-2014 (Table 6). The studies are referred to bythe names SANLAM, ABSA, SAMANCOR, X-STRATA, and LIGHTHOUSE.

NaturPro Scientific LLC reviewed all study data provided and evaluatedthe apparent integrity and completeness of the data, and conductedstatistical analysis, and wrote the reports. Data for each study wasanalyzed independently and then in a pooled analysis that combined studydata of the same duration (12 or 25-27 weeks). All data from subjectscompleting the study were analyzed based on changes in endpoints frombaseline using means, standard deviation and single-factor ANOVA(Microsoft Excel).

Methods

Participants for these studies were recruited through their employer aspart of a wellness initiative. With the exception of ABSA which was 12weeks only, all studies were designed as 12-weeks in duration, with theoption given to subjects to continue the study for an additional 13weeks.

The study subjects participated in one of two treatment groups: theComplete Program, or the Program without the dietary supplement, whichwas named the “Control Program”.

TABLE 6 SUMMARY OF NUMBER OF SUBJECTS AND LENGTH OF STUDIES. SouthAfrica Study Summary Length Subjects Study Weeks (N) Treatment YearSANLAM 12 17 Complete Program 2009 (12 wks) 12 4 Control-Program OnlySANLAM 25 17 Complete Program (Ext 25 wks) 25 4 Control-Program OnlySANLAM 61 (subset of Complete Program (Ext 61 wks) 8 obese) SANLAM 102(subset of Complete Program (Ext 102 wks) 6 obese) ABSA 12 13 CompleteProgram 2010 12 5 Control-Program Only SAMANCOR 12 14 Complete Program2011 12 6 Control-Program Only SAMANCOR 27 (subset of Complete Program(Ext 27 wks) 10) X-STRATA 12 22 Control-Program Only 2012 29 22Control-Program Only LIGHTHOUSE 12 10 Complete Program 2014 16 10Complete Program Pooled 12 Week 12 54 Complete Program Results 12 37Control-Program Only Pooled 25 Week 25-27 27 Complete Program Results25-29 26 Control-Program Only

Intervention

The Program portion of the system included tools for achieving a healthylifestyle which included an eating plan based on portion control andcaloric restriction, behavior modification guidance in the form ofbooklets that included a self-assessment and an exercise guide promotingstrength and circuit training exercise to support cardiovascular andmuscle maintenance and development.

The supplement contained a blend of plant-derived ingredients andminerals consisting of banaba leaf, barberry bark extract, inositol, andchromium. Recommended dosage was 2 capsules twice a day.

The Program including the supplement was termed the “Complete Program”,and the Program without the supplement was named the “Control Program”.

Inclusion and Exclusion Criteria

Adults older than 20 years old, with a body mass index>25 kg/m² wereincluded in all studies. Subjects were required to be healthy,pre-diabetic or diabetic people measured as overweight or obese.Excluded were pregnant or lactating subjects, and individuals with knownallergies to the dietary supplement or any of its ingredients,determined by questionnaire. Subjects were instructed to continue totake all medications that they were prescribed before entering thestudy. Any subsequent changes in medication were made under supervisionof the subjects' personal physicians.

Study Endpoints

In all studies, food and exercise logs were recorded by subjects daily,and clinical and anthropometric measurements such as vital signs andbody weight were measured by full time staff members of the companyconducting the trial. Each had a recognized medical qualification,including registered nurses, a dietician, a biokineticist and apharmacist.

Compliance and Follow-Up

Compliance was based on level of adherence to diet, supplementation andexercise recommendations as well as appearance for study visits. Aminimum average compliance of 50% per subject was required for inclusionin the data analysis. After 26 weeks, obese subjects were invited tocontinue on the program for an additional 26 weeks.

Ethical Requirements

For all studies conducted, informed consent was given by all subjects.Study subjects were not compensated for participation.

Results

Overall, 54 subjects completed 12 weeks on the Complete Program, and 27subjects continued for 25-27 weeks (See Table 6). 37 subjects on thecontrol program completed 12 weeks, and 26 subjects on the controlprogram completed 25-29 weeks. Of eight dropouts, none were due tostudy- or treatment-related issues. Table 18 below provides the reasonsfor all dropouts.

In the SANLAM study, an average of 32.1 and 53.4 pounds were lost after12 and 26 weeks, respectively, in those subjects using the CompleteProgram (Table 8).

TABLE 7 SOUTH AFRICA STUDY SUMMARY AVERAGE STUDY RESULTS IN INDIVIDUALSTUDIES AND IN POOLED RESULTS--SANLAM STUDY Length Subjects Weight LossWeekly Loss Waist Loss Study Weeks (N) Treatment (lb) (lb) (inches)SANLAM 12 17 Complete Program 32.1 2.7 * (12 wks) 12 4 Control-ProgramOnly 8.9 0.7 * SANLAM 25 17 Complete Program 53.4 2.1 6.8 (Ext 25 wks)25 4 Control-Program Only 9.5 0.4 6.3 SANLAM 61 (subset of CompleteProgram 62.0 1.0 10.4  (Ext 61 wks) 8 obese) SANLAM 102 (subset ofComplete Program 83.8 0.8 12.1  (Ext 102 wks) 6 obese) ABSA 12 13Complete Program 16.7 1.4 3.8 12 5 Control-Program Only 7.7 0.6 0.7SAMANCOR 12 14 Complete Program 20.5 1.7 2.2 12 6 Control-Program Only5.5 0.5 2.2 SAMANCOR 27 (subset of Complete Program 32.6 1.2 4.7 (Ext 27wks) 10) X-STRATA 12 22 Control-Program Only 6.7 0.6 * 29 22Control-Program Only 10.4 0.4 2.7 LIGHTHOUSE 12 10 Complete Program 9.00.8 * 16 10 Complete Program 21.6 1.4 5.0 Pooled 12 Week 12 54 CompleteProgram 24.0 2.0 * Results 12 37 Control-Program Only 8.1 0.7 * Pooled25 Week 25-27 27 Complete Program 44.9 1.7 6.8 Results 25-29 26Control-Program Only 8.9 0.3 3.4 * not measured

TABLE 8 AVERAGE BODY WEIGHT FOR SUBJECTS IN THE SANLAM STUDY ON THECOMPLETE PROGRAM. SANLAM (n = 17) Baseline 12 weeks 26 weeks Weight (lb)270.9 238.8 217.4 p-value 0.08 0.0041

A subset of 8 obese subjects in SANLAM who began the study weighing morethan 240 pounds and who completed the initial 25 weeks continued theComplete Program for an additional 36 weeks (61 weeks total) experiencedan average weight loss of 62 pounds (Table 7). The difference frombaseline trended to significance (p<0.059). Six of these subjectscontinued for an additional 41 weeks (102 weeks total), and this groupexperienced an average weight loss of 83 pounds (p=0.03).

A trend for significant reduction in body weight (lb) (p=0.059) wasobserved for 8 obese subjects in SANLAM (arbitrarily coded A-H) whocontinued on the trial for more than one year (61 weeks).

TABLE 9 SANLAM RESULTS IN OBESE SUBJECTS USING THE COMPLETE PROGRAM.Change Subject Baseline 1 year (lbs) A 426 354 −72 B 252 209 −43 C 242176 −65 D 315 252 −63 E 255 176 −79 F 321 255 −67 G 251 224 −27 H 267184 −83 AVG 291 229 −62

ABSA Study

Thirteen subjects on the Complete Program entered and completed the12-week ABSA study. An average reduction in weight of 16.7 pounds wasobserved, although this result was not significant (p=0.46).

TABLE 10 AVERAGE BODY WEIGHT FROM ABSA IN SUBJECTS ON THE COMPLETEPROGRAM. ABSA (n = 13) Baseline 12 weeks Weight (lb) 229.0 212.3 p-value0.46

A subset of four subjects in the ABSA study on the Complete Programcontinued for 43 weeks. An average weight loss of 36.6 lb was observedin these subjects, and the result was significant despite the smallsample size (p=0.05).

TABLE 11 AVERAGE BODY WEIGHT FROM ABSA FOR SUBJECTS CONTINUING ON THESTUDY FOR 43 WEEKS. ABSA (n = 4) Baseline 43 weeks Weight (lb) 186.1149.5 p-value 0.05

SAMANCOR Study

In the SAMANCOR study, 14 subjects using the Complete Program lost anaverage of 20.5 pounds, a result that was not significant due to thesmall sample size.

TABLE 12 AVERAGE BODY WEIGHT FROM SAMANCOR IN SUBJECTS ON THE COMPLETEPROGRAM. SAMANCOR (n = 14) Baseline 12 weeks Weight (lb) 239.4 218.9p-value 0.20

A subset of ten subjects using the Complete Program continued for 27weeks in the SAMANCOR study, resulting in an average weight loss of 32.6pounds, a significant result (p=0.001).

TABLE 13 AVERAGE BODY WEIGHT FROM SAMANCOR FOR SUBJECTS USING THECOMPLETE PROGRAM. SAMANCOR (n = 10) Baseline 27 weeks Weight (lb) 229.7197.1 p-value 0.001

Lighthouse Study

In the LIGHTHOUSE study, an average of 19.9 pounds were lost over 12weeks, a result which was not significant (p=0.38).

TABLE 14 AVERAGE BODY WEIGHT FROM LIGHTHOUSE FOR SUBJECTS USING THECOMPLETE PROGRAM. LIGHTHOUSE (n = 10) Baseline 12 weeks Weight (lb)223.8 203.9 p-value 0.38

Pooled Results

A pooled analysis was conducted on studies with the same durations andstudy design in order to understand overall population effects. Pooledsubjects completing 12 weeks on the Complete Program lost an average of24.0 pounds, an effect which was significant from baseline (p=0.02).Subjects completing 25 weeks on the Complete Program lost an average of44.9 pounds, which was also significant (p=0.0004).

TABLE 15 POOLED RESULTS OF AVERAGE BODY WEIGHT FOR SUBJECTS COMPLETING12- AND 25-WEEK STUDIES. Subjects Length Weight Loss Weekly Loss WaistLoss Study (N) Treatment Weeks (lb) (lb) (inches) Pooled 54 CompleteGOLO Program 12 24.0 2.0 * Pooled 37 Control-Program Only 12 8.1 0.7 *Pooled 27 Complete GOLO Program 25-27 44.9 1.7 6.8 Pooled 26Control-Program Only 25-29 8.9 0.3 3.4 (* not measured).

The changes in body weight for control subjects pooled across the 12-and 25-week studies were similar to those previously published on otherwidely available diet programs. Although subjects in the control grouplost an average of 8.1 and 8.9 pounds over 12 and 25 weeks,respectively, the effect was not significant (p>0.05).

Below, individual pooled 12-week data is shown.

TABLE 16 INDIVIDUAL RESULTS FOR AVERAGE BODY WEIGHT FOR SUBJECTS ON THECOMPLETE GOLO PROGRAM, POOLED FOR SUBJECTS COMPLETING 12 WEEKS. CompleteProgram Pooled 12-weeks Weight (lb) Baseline 12 weeks 255.3 211.2 245.6195.8 267.2 224.2 252.0 218.5 321.2 280.2 201.1 173.9 425.9 369.3 270.3243.2 241.6 218.9 245.1 219.8 240.5 222.2 360.9 282.4 251.3 232.8 315.3284.8 239.9 221.3 208.3 176.4 263.0 239.4 203.0 186.5 240.1 210.5 214.1197.2 242.5 220.3 253.1 218.7 199.5 191.8 255.3 237.9 254.9 229.7 227.7204.4 207.0 181.0 197.1 179.7 249.1 227.5 368.2 339.5 240.3 238.3 249.1228.6 205.8 184.3 295.9 263.0 219.6 203.5 175.0 154.2 228.0 208.6 303.8294.3 165.8 147.3 233.7 210.1 160.2 145.1 212.1 189.2 173.1 150.4 177.0158.3 257.3 244.5 200.6 189.8 297.6 282.2 197.1 183.0 140.4 130.3 297.4292.3 280.9 245.8 181.9 153.4 249.8 230.6 311.3 309.5 243.9 219.9Average

Below, individual pooled 25-week data is shown.

TABLE 17 INDIVIDUAL RESULTS FOR AVERAGE BODY WEIGHT FOR SUBJECTS ON THECOMPLETE PROGRAM, POOLED FOR SUBJECTS COMPLETING 25 WEEKS. CompleteProgram Pooled 25-weeks Weight (lb) Baseline 25 weeks 203.0 188.3 227.7197.1 240.1 196.1 214.1 186.3 253.1 207.2 242.5 202.8 199.5 184.1 255.3228.0 254.9 222.7 207.0 179.7 360.9 229.5 255.3 178.8 245.6 172.6 267.2189.8 252.0 200.2 321.2 255.5 201.1 160.3 425.9 341.9 270.3 224.9 239.9201.1 241.6 205.9 251.3 216.0 208.3 181.7 315.3 275.1 245.1 216.0 240.5212.5 263.0 235.0 255.6 210.7 Average

TABLE 18 WEIGHTS FOR SUBJECTS WITHDRAWING FROM THE STUDIES, AND REASONFOR WITHDRAWAL. Duration Weight (lb) Study (weeks) Baseline End Reasoncited SAN LAM 14 259.9 257.5 became pregnant ABSA 4 151.5 149.5 workstress; failed to attend visits ABSA 8 179.7 172.4 work stress; failedto attend visits SAMANCOR 8 210.1 203.3 alcoholism SAMANCOR 4 419.8399.3 Work stress X-STRATA 0 305.1 NA failed to attend visits X-STRATA 4219.1 207.5 lost interest X-STRATA 8 331.8 289.0 employment change

Example 3 Efficacy of a Diet Program on Body Weight in OverweightAmericans Introduction

The NIH reports that 68.8% of adults in the USA are considered to beoverweight or obese (35.7% obese and 6.3% have extreme obesity). It isgenerally accepted that being overweight increases risk factors forchronic disease. According to the Centers for Disease Control, 29.1million Americans live with type 2 diabetes and 86 million withpre-diabetes. According to the U.S. National Institutes of Health,including the National Institute of Diabetes and Digestive and KidneyDiseases (NIDDK), high body weight and inadequate physical activity aretwo primary causes of insulin resistance and pre-diabetes. For manyoverweight people, changing dietary habits is key to maintaining ahealthy body weight.

This report summarizes a pilot study performed in the USA to evaluatethe safety and efficacy of a weight loss system originally developed andtested in South Africa by physicians at the Medical NutritionalInstitute (MNI) in Johannesburg, South Africa, to provide a moreeffective weight loss solution.

Background

MNI was started in 2002 to focus on weight management and healthcaretraining services. MNI developed the weight loss system to addressprevious limitations of corporate wellness programs to deliversustainable weight loss and measurable health benefits. Conrad SmithM.D. and Mariaan Du Plessis (registered pharmacist) developed anapproach to improve insulin management during weight loss programs. MNIdeveloped a 3-tiered solution centered on insulin management inconjunction with caloric control and intervention with a plant andmineral based dietary supplement, containing ingredients researched toaddress insulin performance. MNI implemented two studies withincorporate wellness programs in 2009 and 2010 and an additional threestudies from 2011 through 2014.

In 2010, MNI partnered with GOLO, LLC in the USA (Newark, Del.), andGOLO implemented a pilot study in 2011 to understand whether the initialresults in South Africa could be replicated in a separate population ofsubjects.

Methods

A 26-week, open-label pilot study of 35 overweight/obese human subjectswas conducted in Delaware in the United States by the marketer GOLO todetermine the efficacy of a weight loss program “GOLO for Life”. Thestudy was conducted in the U.S. in 2010-2011 and recruited 49 subjects.Study participants were recruited through local newspaper ads and localpostings. The study was comprised of weekly study visits with key datacollected at baseline, 30 days, 90 days, and 26 weeks (Study 1), with anoption for subjects to continue with the study for an additional 26weeks (Study 1a). At study completion after 26 weeks, 23 subjects optedto continue on the program as a maintenance study for an additional 26weeks. Each subject's baseline values were recorded and served as thebasis by which the program's efficacy was measured.

TABLE 19 OVERVIEW OF STUDIES ON DIET PROGRAM. Study# Location N* Weeks 1United States 35 26 1a United States 23 52 *N is the number of subjectscompleting the study. Study #la is the continuation of study #1 after anadditional 26-week follow-up.

The Diet Program

The diet program included behavior modification guidance in the form ofbooklets that included a self-assessment, an eating plan based on foodgroups, portion control and caloric restriction, and a dietarysupplement as three capsules, three times per day. The supplementcontained a blend of plant-derived ingredients and minerals consistingof banana leaf, barberry bark extract, apple fruit extract, salacia barkextract, gardenia fruit extract, rhodiola root, inositol, chromium, zincand magnesium. The diet program used in this study may be bestcategorized as self-directed, with counseling and support availableonline, by email communications, or through a toll-free phone number.Subjects were provided with written handouts for the meal plan thatincluded guidance on serving recommendations from the major food groups,with portion control and a self-assessment behavioral handout. Subjectswere also provided with food and exercise logs. Subjects were directedto attempt 15 minutes of exercise per day or 105 minutes per week and topreferably exercise using high intensity workouts (HIT) such as walkingwith 30 second bursts and 30 second rest periods. Optional exerciseclasses were made available to the subjects twice per week.

Study Criteria

Adults older than 20 years old, with a body mass index>25 kg/m² wereincluded in the study. Subjects were required to be healthy overweightor obese. Excluded were type 2 diabetics, pregnant or lactatingsubjects, determined by questionnaire, and individuals with knownallergies to the dietary supplement or any of its ingredients. Subjectswere instructed to continue to take all medications that they weretaking at the time that the study began. Any subsequent changes inmedication were made under supervision of the subjects' personalphysician. Subjects were not compensated to join the trial or forparticipating in the trial.

Subjects were requested to visit the study center weekly with a minimummonthly visit to remain in the study. At each visit, body weight, bodymass index (BMI), visceral fat, body fat, muscle loss and metabolic ageas measured by a Tanita Body Composition Analyzer SC-331S were measured.

Body circumference measurements were taken at the waist, shoulders,chest, bicep, hips and thighs, and blood pressure (mmHg) and heart ratewere also measured. Subjects provided completed food and exercise logsat the visit and their feedback on the Program. Subjects self-reportedchanges in dress and pants sizes. Front and side pictures of allsubjects were taken at baseline and various intervals and at end pointsto verify results. Medication history and reduction or elimination ofmedications was also recorded.

At baseline, 3 months, and 6 months, blood work was taken and fastingblood glucose (mg/dL), HbAlc (% DCCT) and blood lipids (triglycerides,total cholesterol, LDL, HDL) were measured using LabCorp or equivalentclinical chemistry providers.

Compliance

Compliance was measured at each weekly visit and at least monthlythrough exercise logs and food logs kept by subjects, and a count ofsupplement capsules remaining during each study visit. A minimum averagecompliance of 50% was required for inclusion in the data analysis.Compliance was based on level of adherence to diet, supplementation andexercise recommendations.

Ethical Requirements

Informed consent was obtained for all subjects. Study subjects were notcompensated for participation. No institutional review board was used.

Data Analysis

Blake Ebersole (NaturPro Scientific LLC, Carmel, Ind.) reviewed all dataprovided by GOLO, LLC, evaluated the apparent integrity and completenessof the data, conducted statistical analysis, and wrote the report. Alldata from subjects completing the study were analyzed based on changesin endpoints from baseline using means, standard deviation andsingle-factor ANOVA using Microsoft Excel.

Results

Out of 49 subjects entering the study, 35 completed the full 26 weekstudy. Of the 14 subjects who left the study, none were due to adverseevents (Table 21). Data from dropouts were not included in the analysisof group results if they did not reach the 26 week mark and completeblood work. All drop out subjects lost weight, with data and reason fordropping out stated in Table 21 below.

After 7 days, body weight in 34 subjects was reduced by an average of3.4 lbs., and after 30 days, an average of 7.7 lbs. weight loss wasobserved (FIG. 1). One subject did not report data at 7 days and 30days. After 90 days, average body weight was reduced by 20 pounds, andwaist circumference was reduced by an average of four inches. After 26weeks, the average weight loss was 30.9 pounds, which was significantfrom baseline (p<0.005) (FIG. 2). The average decrease in BMI at 26weeks was 4.8 units (FIG. 3).

Average waist circumference, pants and dress size, fat percentage, totalcholesterol, and triglycerides all decreased significantly from baselineafter 26 weeks (Table 20). Muscle loss did not significantly decrease,suggesting the diet program reduced body fat without significant loss ofmuscle mass. For the subjects who remained in the study for anadditional 26 weeks, all measures continued to be a significantreduction from baseline, except for total cholesterol.

TABLE 20 SUMMARY OF DATA IN THE U.S. DIET STUDY, BASED ON AVERAGEVALUES. VALUES IN RED WERE NOT SIGNIFICANT (P > 0.05). 26 Weeks 1 YearBaseline 90 Day (n = 35) (n = 23) Weight 210.8 191.4 178.8 167.8 (lbs)−19.3 ± 8.86 −30.9 ± 11.1 −36.6 ± 14.7 (p = 0.069) (p = 0.0024) (p =0.000049) Waist 42.1 39.0 35.7 34.5 Circumference −3.09 ± 1.70 −5.48 ±1.75 −6.94 ± 2.52 (in) (p = 0.02) (p = 0.000031) (p = 0.0000016) BMI32.9 28.1 25.9 −4.8 ± 1.8 −6.1 ± 3.0 (p = 0.00084) (p = 0.0000025) DressSize 16.2 9.33 7.3 −7 ± 2 −8 ± 2 (p = 0.000024) (p = 0.0000049) PantsSizes 40.7 35.5 33.6 (waist inches) −5.27 ± 1.01 −7.6 ± 2.6 (p =0.00025) (p = 0.00078) Muscle (lbs) 129.7 122.7 127.3 −7.1 ± 5.1 −2.3 ±7.0 (p = 0.24) (p = 0.75) % Muscle 62.30% 69.20% 75.90%  6.9% ± 4.3%12.5% ± 4.6% (p = 0.00067) (p = 0.0000017) Fat (lbs) 80.0 56.2 40.4−23.8 ± 11.7 −34.3 ± 12.6 (p = 0.00074) (p = 0.000000017) % Fat 37.60%30.80% 24.10% −6.9% ± 4.3% −12.5% ± 4.6%  (p = 0.00068) (p = 0.0000017)Cholesterol 184.5 166.9 174.7 −17.6 ± 33.9  −7 ± 38 (p = 0.041) (p =0.50) LDL 105.5 91.5 94.4 −13.9 ± 29.1  −8 ± 31 (p = 0.69) (p = 0.38)HDL 57.4 60.5 64.8  3.11 ± 9.93  9 ± 16 (p = 0.41) (p = 0.064)Triglyceride 108.3 74.4 76.9 −33.9 ± 48.1 −37 ± 55 (p = 0.0037) (p =0.0067) CHL/HDL 3.51 2.88 2.88 ratio −0.63 ± 0.90 −0.64 ± 1.23 (p =0.020) (p = 0.07) HDL/LDL ratio 2.05 1.61 1.61 −0.44 ± .070 −0.42 ± 0.98(p = 0.035) (p = 0.13)

According to the NIDDK, fasting blood glucose and hemoglobin Ale (HbAlc)are primary indicators of blood sugar health and insulin resistance. At26 weeks fasting blood glucose was reduced by an average of 8.5%(p<0.01) and HbAlc was reduced by an average of 3.9% (5.79 to 5.56,p=0.011) (FIG. 5). In a subset of 24 healthy pre-diabetic subjects withbaseline HbAlc levels between 5.7 and 7.1, an average 6.9% decrease wasfound at 90 days (p<0.0001). A 4% average reduction was observed after26 weeks, which was significant (p=0.002). At 52 weeks, an average 7.3%decrease was found in these subjects (p<0.001).

In all subjects, average systolic and diastolic blood pressure wasreduced by 12.5% (p<0.001) and 6.0% (p<0.05), respectively after 26weeks (FIG. 6).

Visceral fat was significantly reduced over 26 weeks by an average of28% (from 10.00% to 7.19%, p=0.005, FIG. 7) and by an average of 37% insubjects who continued for 39-55 weeks (from 10.00% to 6.32%, p<0.0001).Of the 35 subjects, 11 had a visceral fat percentage greater than 13% atthe start (average 15.82%). At 26 weeks, the average visceral fatpercentage for these 11 subjects was 11.45%.

Metabolic age, calculated from body composition analysis, also decreasedfrom an average of 56.3 to 43.2 years of age (p<0.0001) at 26 weeks.Although metabolic age is an estimated value, it can be used assupportive data with respect to the number of other improvementsobserved in this study on primary biomarkers such as body weight.

Fourteen (14) of the USA study participants had been prescribed a totalof 35 medications at the start of the study. After 26 weeks, more thanhalf (18) prescription medications were eliminated, and 6 wereprescribed at a lower dosage, all under the supervision of the subjects'personal physician. 14 subjects left the study before 26 weeks due tovarious factors (Table 21). No dropouts were due to adverse events. Alldropouts showed a reduction in weight.

TABLE 21 BODY WEIGHT CHANGES FROM SUBJECTS WHO DISCONTINUED THE 26-WEEKSTUDY. Baseline End Difference Weeks (lb) (lb) (lb) in Study Reasons 227212.6 −14.4 16 Family issues 205 191.6 −13.4 12 Unknown 173.4 165.6 −7.810 Moved away 225.8 221.6 −4.2 9 Husband made her stop 140.4 135.6 −4.87 Work 240.4 229.6 −10.8 5 Drug problem 210.4 199.8 −10.6 5 Mother sick274.6 268.2 −6.4 8 Health issues 168.8 155.6 −13.2 14 Travelling time151.2 123.2 −28 14 Time issues 184.6 177.2 −7.4 7 Scheduling conflicts165.4 145.2 −20.2 20 Time issues 151.4 139.6 −11.8 15 Pregnancy 232.4218 −14.4 13 Changed jobs-too far

Discussion

The diet program used in this study combines diet, exercise andnutritional supplementation together into a self-directed program. Anumber of studies have been performed using similar diet programs. Arecent meta-analysis was performed that categorized randomizedcontrolled human trials on diet programs into three categories: 1)“market leaders” such as Nutri-System® and Weight Watchers®, 2)very-low-calorie meal replacements, and 3) self-directed programs suchas Atkins® and SlimFast®. Most of the diet plans studied combineface-to-face and group counseling, medical supervision, packaged foodsor diet plans, and exercise recommendations.

The range of weight loss in 6-month studies on market leaders wasbetween 3.6 and 8.1% of total body weight. Meanwhile, weight loss forvery-low-calorie meal replacement programs ranged between 1.9 and 22%for study durations between 3 and 9 months, with most studies reportingan average reduction lower than 8%. For self-directed programs, studiesranging from 3-12 months demonstrated a range of average weight lossbetween 0 and 8.7%, with the predominant number of studies averagingless than 5% weight loss. The diet program used in this study may bebest categorized as self-directed, with counseling and support availableonline, by email communications, or through a toll-free phone number. Inthis study, an average weight loss of 13% was observed in 26 weeks,which compares favorably to previous studies on self-directed programs.In addition to improvements in body weight and BMI, a number of bloodmarkers associated with poor diet, cardiometabolic syndromes, andinsulin resistance, including fasting blood sugar and HbAlc, were alsoimproved compared to baseline values.

Glycated hemoglobin Ale (HbAlc) is a marker long used by physicians todetermine a patient's average blood glucose levels over the previous8-12 weeks. For this reason, HbAlc is generally considered a morereliable marker than fasting blood glucose to reflect average levels ofblood glucose. Insulin resistance occurs when cells in the body are lessresponsive to insulin, which can lead to increases in blood sugarreflected in HbAlc and FBG levels. Thus, a reduction in HbAlc levels,along with improvements in body weight, together may indicate animprovement in insulin resistance. For example, changes in insulinresistance and HbAlc can be caused by exercise-mediated changes in bodycomposition in older adults with type-2 diabetes. Other diet programshave also measured improvements in HbAlc and body weight. A 2016 studyon Weight Watchers® showed a significant 6-month weight loss of 5.5%,and a significant decrease in HbAlc in pre-diabetic subjects followingthe program. A health coaching program in diabetics with a lowsocioeconomic status was also shown to reduce body weight, waistcircumference and HbAlc.

The diet program used in the current study appeared to improve bodyweight favorably, consistent with previous studies on other similar dietprograms. The diet program used in this study was affordable and did notrequire office visits, or food to be purchased, aside from an includeddietary supplement requiring the consumption of three capsules per day.These factors could help to contribute to long-term compliance for abroader spectrum of people, as well as for those who have more weight tolose and need a long-term weight loss plan.

As with any study, dropouts and side effects can be a concern for weightloss plans. However dropouts from the studies all had reduced bodyweight at the time of withdrawal, and no withdrawals were due totreatment or study-related effects. Based on this early data, the dietprogram in this study may be an effective program that can beself-directed and also easily monitored by health coaches or physicians.

Although subjects were used as their own controls in this study, datafrom control groups in studies of other diet programs allow for somemeaningful comparisons to be made. The amount and percentage of weightloss observed in this study was consistent with data reported by similarprograms such as Weight Watchers and Nutrisystem. Despite the lack of aseparate control group, an abundance of control data has been published.Further, the high degree of clinical relevance and supporting evidenceon the individual elements of the intervention in this study adds aconsiderable degree of strength to the results observed. Larger studiesare planned on the program to determine whether the effects observed canbe repeated in other populations, and in larger sample sizes over longerdurations.

Overall, subjects in this study showed significant reductions in bodyweight and BMI, and also experienced improvements in several markers ofmetabolic function. The data is consistent with previous results fromthe program, and with published data supporting the elements of theprogram. Thus, the effects observed in this study on a combination ofdietary and behavioral interventions support the effectiveness of theGOLO for Life program for weight loss and several related clinicalendpoints.

TABLE 22 INDIVIDUAL WEIGHT LOSS AFTER 26 WEEKS. Baseline 26 weeksDifference Difference Subject # (lb) (lb) (lb) (%) 1 205.8 174.6 −31.2−15% 2 220.8 189.2 −31.6 −14% 3 238.0 203.6 −34.4 −14% 4 205.0 189.0−16.0  −8% 5 155.6 143.0 −12.6  −8% 6 177.8 152.6 −25.2 −14% 7 238.0185.2 −52.8 −22% 8 192.6 156.0 −36.6 −19% 9 246.0 206.0 −40.0 −16% 10220.2 184.4 −35.8 −16% 11 156.8 135.8 −21.0 −13% 12 197.0 153.4 −43.6−22% 13 182.6 152.6 −30.0 −16% 14 213.8 183.0 −30.8 −14% 15 233.0 190.6−42.4 −18% 16 182.6 163.6 −19.0 −10% 17 375.4 332.4 −43.0 −11% 18 188.0162.8 −25.2 −13% 19 201.4 161.8 −39.6 −20% 20 250.2 221.6 −28.6 −11% 21173.2 144.0 −29.2 −17% 22 172.0 157.2 −14.8  −9% 23 183.2 152.8 −30.4−17% 24 206.4 160.4 −46.0 −22% 25 173.4 139.6 −33.8 −19% 26 240.2 188.6−51.6 −21% 27 273.8 241.2 −32.6 −12% 28 265.0 226.0 −39.0 −15% 29 237.4198.2 −39.2 −17% 30 248.8 239.6 −9.2  −4% 31 162.2 141.0 −21.2 −13% 32183.4 160.8 −22.6 −12% 33 189.2 151.0 −38.2 −20% 34 172.4 161.0 −11.4 −7% 35 180.0 157.0 −23.0 −13% Average 209.7 178.8 −30.9 −15%

TABLE 23 SUMMARY OF RESULTS AFTER 26 WEEKS. 26 Week USA SummaryParticipants # 35 Trial Length weeks 26 Average Weight lb −30.9 AverageWeight Change Per Week lb −1.2 % Body Weight % −13.4 Muscle Mass lb −7.1Fat lb −23.8 BMI % −14.6 Visceral Fat % −27.9 Total Inches inches −23.3Waist Size inches −6.0 Dress Size Sizes −3.4 Pants Size Sizes −5.3 FoodCompliance % 73.9 Exercise Compliance % 73.2 Blood Pressure Systolic %−12.5 Blood Pressure Diastolic % −5.9 Total Cholesterol % −9.6 LDL %−13.2% HDL % 5.4% Triglycerides % −31.3% Glucose % −8.5% A1C % −3.9%Cholesterol/HDL Ratio % −14.2% LDL/HDL Ratio % −17.7% Metabolic SyndromeRisk Factors Baseline 114 Metabolic Syndrome Risk Factors 26 wks. 50Metabolic Syndrome Baseline 24 Metabolic Syndrome 26 wks. 5 Pre DiabeticBaseline 23 Pre Diabetic 26 wks. 12

Example 4

Further studies have been planned to further evidence the surprising andunexpected results shown in previous studies. Such studies may be amulti-arm study, such as two arm, three arm or four arm study for theweight loss composition, the weight management plan, and/or the bulkfood product of embodiments herein. An exemplary study may include acomparison of the weight management composition of embodiments herein toa placebo, the weight management composition of embodiments herein andthe weight management plan of embodiments herein to a placebo, and/orthe weight management composition of embodiments herein and the weightmanagement plan of embodiments herein to a control diet. The plannedstudies are expected to fully support the superior results seen in paststudies.

Although the present invention has been described in considerable detailwith reference to certain preferred embodiments thereof, other versionsare possible. Therefore the spirit and scope of the appended claimsshould not be limited to the description and the preferred versionscontained within this specification.

1. A weight loss composition comprising banaba leaf extract in an amountof about 20 mg to about 100 mg, apple fruit extract in an amount ofabout 30 mg to about 100 mg, Rhodiola root extract in an amount of about140 mg to about 400 mg, corosolic acid, magnesium chelate, and zincchelate.
 2. (canceled)
 3. The weight loss composition of claim 1,further comprising at least one of the following: chromium, gardeniafruit extract, salacia extract, inositol, and berberine.
 4. The weightloss composition of claim 3, wherein the chromium is in a chelated form.5. (canceled)
 6. A method for promoting weight loss in a subjectcomprising administering to the subject the weight loss composition ofclaim
 1. 7. The method of claim 6, wherein the magnesium, zinc, or bothare in a chelated form.
 8. The method of claim 6, wherein the weightloss composition further comprises at least one of the following:chromium, gardenia fruit extract, salacia extract, inositol, andberberine.
 9. The method of claim 8, wherein the chromium is in achelated form.
 10. The method of claim 6, wherein the weight losscomposition comprises banaba leaf extract in an amount of about 56 mg,apple fruit extract in an amount of about 45 mg, Rhodiola root extractin an amount of about 340 mg, magnesium chelate in an amount of about 45mg, zinc chelate in an amount of about 30 mg, berberine hydrochloride inan amount of about 105 mg, inositol in an amount of about 210 mg,Salacia extract in an amount of about 45 mg, gardenia fruit extract inan amount of about 90 mg, and chromium chelate in an amount of about 210mcg.
 11. The method of claim 6, wherein the subject is following aweight management plan comprising establishing a food index whichincludes four categories of food, namely vegetables, proteins,carbohydrates (including starches and fruit), and fat, by defining aportion for each category and assigning a food value to each respectiveportion based on the following formula: B−F−P+S+FT+PC=FV, wherein B is abase energy value determined by dividing the calorie value of the foodportion by a factor of 2.7 to 3, F is fiber content, P is proteincontent, S is sugar content, FT is fat content, and PC is processedcontent; determining a subject's base food allowance based on at leastone or more of the following parameters of the subject: gender, age,height, BMI, weight, and life activity; establishing an activity indexbased on values assigned to time interval and activity performed; anddetermining, for the subject, a daily food allowance as the sum of thebase food allowance and values obtained from the activity index due tocorresponding activities that are listed in the activity index beingperformed by the subject, wherein the food values are in a predeterminedrelationship to the daily food allowance.
 12. The method of claim 6,wherein the subject is using a bulk food product to follow a weightmanagement plan, wherein the bulk food product comprises a plurality ofmeal portions, each meal portion including protein, fat, carbohydratefrom a starch source, carbohydrate from a vegetable source, fiber, and aphyto blend comprising mushroom powder, moringa leaf extract, gingerrhizome extract, turmeric rhizome, saffron, Bacillus subtilis, Bacilluscoagulans, a natural supplement blend, digestive enzymes, fruits,vegetables, herbs, wheat grass, flax, wheat germ, probiotics, or acombination thereof.
 13. The method of claim 12, wherein the weightmanagement plan comprises establishing a food index which includes fourcategories of food, namely vegetables, proteins, carbohydrates(including starches and fruit), and fat, by defining a portion for eachcategory and assigning a food value to each respective portion based onthe following formula: B−F−P+S+FT+PC=FV, wherein B is a base energyvalue determined by dividing the calorie value of the food portion by afactor of 2.7 to 3, F is fiber content, P is protein content, S is sugarcontent, FT is fat content, and PC is processed content; determining asubject's base food allowance based on at least one or more of thefollowing parameters of the subject: gender, age, height, BMI, weight,and life activity; establishing an activity index based on valuesassigned to time interval and activity performed; and determining, forthe subject, a daily food allowance as the sum of the base foodallowance and values obtained from the activity index due tocorresponding activities that are listed in the activity index beingperformed by the subject, wherein the food values are in a predeterminedrelationship to the daily food allowance.
 14. (canceled)
 15. (canceled)16. A kit comprising the weight loss composition of claim 1, andinstructions for a weight management plan designed to stabilize andoptimize insulin levels.
 17. (canceled)
 18. (canceled)
 19. A kitcomprising the weight loss composition of claim 1; and a bulk foodproduct comprising a plurality of meal portions, each meal portionincluding protein, fat, carbohydrate from a starch source, carbohydratefrom a vegetable source, fiber, and a phyto blend comprising mushroompowder, moringa leaf extract, ginger rhizome, turmeric, saffron,Bacillus subtilis, a natural supplement blend, digestive enzymes,fruits, vegetables, herbs, wheat grass, flax, wheat germ, probiotics, ora combination thereof.
 20. (canceled)
 21. The kit of claim 19, whereinthe weight loss composition comprises banaba leaf extract in an amountof about 56 mg, apple fruit extract in an amount of about 45 mg,Rhodiola root extract in an amount of about 340 mg, magnesium chelate inan amount of about 45 mg, zinc chelate in an amount of about 30 mg,berberine hydrochloride in an amount of about 105 mg, inositol in anamount of about 210 mg, salacia extract in an amount of about 45 mg,gardenia fruit extract in an amount of about 90 mg, and chromium chelatein an amount of about 210 mcg.
 22. The kit of claim 19, wherein theweight management plan comprises establishing a food index whichincludes four categories of food, namely vegetables, proteins,carbohydrates (including starches and fruit), and fat, by defining aportion for each category and assigning a food value to each respectiveportion based on the following formula: B−F−P+S+FT+PC=FV, wherein B is abase energy value determined by dividing the calorie value of the foodportion by a factor of 2.7 to 3, F is fiber content, P is proteincontent, S is sugar content, FT is fat content, and PC is processedcontent; determining a subject's base food allowance based on at leastone or more of the following parameters of the subject: gender, age,height, BMI, weight, and life activity; establishing an activity indexbased on values assigned to time interval and activity performed; anddetermining, for the subject, a daily food allowance as the sum of thebase food allowance and values obtained from the activity index due tocorresponding activities that are listed in the activity index beingperformed by the subject, wherein the food values are in a predeterminedrelationship to the daily food allowance.